International Journal of Obesity (2006) 30, 1565–1573 & 2006 Nature Publishing Group All rights reserved 0307-0565/06 $30.00 www.nature.com/ijo ORIGINAL ARTICLE Mail and phone interventions for weight loss in a managed-care setting: weigh-to-be 2-year outcomes NE Sherwood1, RW Jeffery2, NP Pronk1,3, JL Boucher3, A Hanson1, R Boyle1, K Brelje2, K Hase1 and V Chen2 1 HealthPartners Research Foundation, Minneapolis, MN, USA; 2Division of Epidemiology, University of Minnesota School of Public Health, Minneapolis, MN, USA and 3HealthPartners Center for Health Promotion, Minneapolis, MN, USA Objective: Evaluate effectiveness of weight-loss interventions in a managed care setting. Methods: Three-arm randomized clinical trial: usual care, mail, and phone intervention. Participants were 1801 overweight managed care organization (MCO) members. Measures included baseline height, weight at baseline and 24 months, selfreported weight at 18 months. Intervention and participation in other weight-related programs was monitored across 24 months. Results: Weight losses were 2.2, 2.4, and 1.9 kg at 18 months in the mail, phone, and usual care groups, respectively. Mail and phone group weight changes were not significantly different from usual care (Po0.35).Weight losses at 24 months did not differ by condition (0.7 kg mail, 1.0 kg phone, and 0.6 kg usual care, P ¼ 0.55). Despite treatment availability over 24 months, participation diminished after 6 months. Participation was a significant predictor of outcomes in the mail and phone groups at 18 months and the mail group at 24 months. Cost-effectiveness of phone counseling was $132 per 1 kg of weight loss with mail and usual care achieving similar cost-efficiency of $72 per 1 kg of weight loss. Conclusion: Although mail- and phone-based weight-loss programs are a reasonably efficient way to deliver weight-loss services, additional work is needed to enhance their short- and long-term efficacy. International Journal of Obesity (2006) 30, 1565–1573. doi:10.1038/sj.ijo.0803295; published online 21 March 2006 Keywords: weight loss; managed care; phone; mail Introduction Obesity is emerging as an increasingly important public health problem.1–4 Current estimates from the National Center for Health Statistics suggest that more than a third of adults are obese, with an additional 30% classified as overweight.4 Overweight and obesity increase the risk of many serious health conditions, including hypertension, hypercholesterolemia, diabetes, coronary heart disease, and some forms of cancer.5–8 Obesity is fast approaching tobacco as the leading contributor to premature death in the United States.9 Despite the major health significance of obesity, health care providers currently have few obesity management options. Current pharmacological treatments are only modestly effective relative to cost10,11 and bariatric surgery is not appropriate for many patients and prohibitively Correspondence: Dr NE Sherwood, HealthPartners Research Foundation, PO Box 1524, MS 21111R, Minneapolis, MN 55440-1524, USA. E-mail: [email protected] Received 29 June 2005; revised 16 December 2005; accepted 9 January 2006; published online 21 March 2006 expensive as a public health strategy.12 Other treatments, including intensive behavioral treatments requiring multiple in-person contacts, are also too expensive for widespread use and only modestly effective.13 Participation in these treatment programs is also relatively low. Less than 50% of overweight women and 20% of overweight men have ever participated in a formal weight-control program,14,15 and about two-thirds of these are low-cost commercial programs with very high dropout rates.16,17 Cost-effective approaches that can reach a broad population of individuals are needed. Mail and/or phone-based counseling approaches may be viable alternatives to expensive in-person clinic visits.18–24 However, the efficacy of these types of lower-intensity interventions needs to be evaluated.25 The present report describes 2-year results of the Weigh-ToBe study (WTB), the first ever large-scale randomized trial examining the efficacy of nonclinic-based weight-loss interventions in a health care delivery system. WTB compared mail and phone-based weight loss interventions to usual care in a managed care setting. This report compares the three treatment groups in terms of level of member participation, weight loss efficacy, and cost. Additionally, associations Mail and phone interventions for weight loss in a managed-care setting NE Sherwood et al 1566 between program participation and weight outcomes are examined. Materials and methods This project was a collaboration among the University of Minnesota School of Public Health, the HealthPartners Research Foundation, and the HealthPartners Center for Health Promotion (CHP). Study recruitment began in August 1999 and data collection was completed for all study participants in October 2002. HealthPartners is a mixedmodel managed care organization (MCO) that provides medical care service for approximately 700 000 members in the Minneapolis/St Paul, Minnesota metropolitan area. The study was a randomized trial evaluating the effectiveness of phone-based and mail-based interventions for weight reduction offered to members in comparison to usual care over 2-years. Recruitment targeted overweight MCO members from four clinics. Two clinics served members in St Paul and Minneapolis and two served individuals in adjacent suburbs. Participant recruitment was conducted over 12 months using several methods. Direct mail announcements were sent to the households of 31 000 clinic members. Posters and flyers were displayed in each of the four clinics. Referrals from clinic physicians and nurses were encouraged by e-mail announcement and presentations at staff meetings. The study was also advertised on the MCO web site. Prospective study participants were instructed to call a study phone number for information about the project.26 Eligibility criteria were intentionally broad. Inclusion requirements included age 18 years or older and body mass index (BMI) greater than 27.0 based on reported height and weight. Age and weight eligibility were ascertained in the informational phone call. A clinic visit at one of the participating clinics was also scheduled at that time. Individuals attending this visit had the study described to them and signed an informed consent statement approved by the Human Subjects Review Committees of both the University of Minnesota and HealthPartners Research Foundation. After consent, weight and height were measured using a calibrated balance-beam scale and a wall-mounted ruler. Questionnaires, described further below, were also completed. Overall, 3294 individuals requested information about the study, 2205 met the eligibility criteria and of those, 1801 completed the baseline consent process, and enrolled in the study. Seventy-five percent of enrolling participants indicated that they learned of the study through the mailed announcements, 14% through clinic posters, 4% from physician referral, 4% by word-of-mouth, 1% from the web site, and 2% other source. Following baseline, the Project Manager randomized participants using an automated computer system to one of three conditions: mail intervention, phone intervention, and usual care. The randomization scheme consisted of International Journal of Obesity blocks of 15 with the numbers 1–3 to indicate treatment group (phone, mail and usual care); the randomization sequence was concealed until after interventions were assigned. After randomization, participants were sent a letter informing them of their assignment. To measure relative interest in the two treatment conditions, participants were asked to notify the study when they wished to begin their program. Mail intervention individuals were asked to indicate their readiness by sending a postcard to the study office. Phone treatment individuals were given a phone number to call to activate treatment. Once activated, the two weight loss interventions proceeded in parallel formats. Both were comprised of 10 interactive lessons designed to be completed in sequence with feedback between each lesson from a health counselor. Each lesson included instructional material describing a rationale for a specific behavior change strategy, behavior change goals related to that strategy, and homework to be completed before beginning the next lesson. Lesson topics included nutrition, physical activity, and behavior management techniques (e.g., behavioral assessment, goal setting, stimulus control, social support, and self-motivation). The primary homework assignment was to keep a food and exercise log. Weight management lessons were designed to be completed as rapidly as one lesson per week. However, study participants were encouraged to proceed at a pace comfortable for them. For phone intervention individuals, all 10 lessons and homework assignment materials were mailed at the beginning of the program. A series of calls was scheduled between the participant and a phone counselor to provide guidance through each lesson and feedback about progress. Phone counselors were staff members of the CHP and were trained nutritionists and/or exercise specialists.27 During an introductory telephone call, program format and expectations were explained and subsequent calls were scheduled. These calls were comprised of discussion of behavioral strategies tried since the last session, discussion of content and activities for the lesson, counselor advice about how to improve/maintain lifestyle behaviors, goal setting, and counselor description of the rationale and behavioral assignment for the next lesson. The average length of calls was 19 min. Mail intervention used the same 10 written lessons, behavioral assignments, and counseling protocol and staff. However, interactions between counseling staff and participants were entirely by mail. Participants were first mailed a course manual with two lessons and two feedback forms and were instructed to complete the first lesson and return a progress report. Progress report information included behavior change goals, perceived progress, and action steps taken to achieve goals. When this progress report was received by the counselor, she reviewed it and made comments in writing, which were forwarded, along with the next session, by return mail. This sequence was repeated for each lesson until the course was completed. Mail and phone interventions for weight loss in a managed-care setting NE Sherwood et al 1567 Follow-up intervention options were available to both the phone and the mail groups after completion of the 10-lesson course. These were comprised of individual follow-up on topics of the participant’s choosing. Resources available to the counselor included a wide range of educational resources on lifestyle topics related to weight management maintained by the CHP. Participants could also enroll in other CHP health-related courses. Additionally, participants could repeat all or any part of the WTB intervention. Participants who discontinued contact with their counselor prior to course completion were contacted at 1-, 2-, and then 6month intervals for up to 2 years to encourage intervention resumption. Individuals who did not activate their assigned intervention were also contacted at 6-month intervals to encourage engagement. Usual care participants had access only to weight management services generally available to members of HealthPartners. After randomization, they were sent a resource sheet detailing MCO and community weight management options including free general phone counseling, a structured weight management phone course, or a group class offered at several MCO clinics. The phone course and group classes required a modest fee of $25. Similar to participants in the treatment groups, usual care participants could enroll in other CHP health-related courses. Study measures The WTB project encompassed 24 months for each study participant. At baseline and 24 months, clinic visits were held at which body weight was measured and self-report measures were completed. Measurement staff were blind to study condition. Between these time points, follow-up assessments were conducted by mailed questionnaire at 6, 12, and 18 months. Self-reported weight was obtained at these time points. 6 and 12-months outcomes have been reported previously28 and 18 and 24-month outcomes are reported here. The following information is included in this report. Demographic characteristics: Measures at baseline included gender, age (year), education (phigh school, 4high school education but ocollege degree, Xcollege degree or greater), ethnicity (white vs other), and marital status (currently married; separated, divorced, or widowed; never married). Smoking status: Currently smoking (yes/no), measured every 6 months. Weight status: BMI was computed from weight and height (kg/m2) for each time point. A categorical weight status variable was also created: overweight (BMI 25–29.9); Class I obesity (BMI 30–34.9), Class II obesity (BMI 35–39.9), and Class III obesity (BMIX40). Measured weight was obtained at the baseline and 24-month follow-up clinic visits; selfreported weight was obtained at 18-months. Weight loss history: Ever dieted (yes/no) and participated in a formal weight loss program in the last 2 years (yes/no), measured at baseline. Current medication use: Diabetes (yes/no), depression (yes/ no), and cardiovascular disease (yes/no), measured at baseline. Participation measures: Weight control activity participation was assessed in two ways using the tracking systems that are part of the CHP delivery platform.27 These records document the dates and types of all contacts between CHP staff and members, both for the WTB program and other CHP programs. Analysis variables for mail and phone group participants included enrollment status (yes/no) and number of WTB course sessions completed (0–10). Additionally, the total number of weight-related encounters outside of the WTB protocols were examined. The operational definition of an ‘encounter’ was an educational interaction that focused on the topics of weight, diet, and/or physical activity between CHP staff and a participant. This information was available for all three study conditions. Analysis The primary outcomes examined in this study are changes in body weight from baseline to 18 and 24 months. A required sample size of 500 participants was determined using calculations to have 90% power (a ¼ 0.05, two-tailed) to detect a small effect size for intent-to-treat analyses. Data analyses were performed using the general linear models programs of SAS (Version 8.7). First, group differences in weight change at 18 and 24 months were examined controlling for baseline weight. Second, group differences in weight change at 18 and 24 months were examined controlling for baseline body weight and individual-level factors significantly associated with weight change. Third, treatment participation was compared between the mail and phone groups and outcomes were examined as a function of enrollment status and participation, categorized into three groups: no lessons completed (included individuals not active in treatment), 1–9 lessons, and 10 lessons completed. Finally, the relationship between number of weight-related encounters and weight loss outcomes was examined across all three groups. These analyses used an intent-to-treat approach in which baseline values for body weight (0 weight loss) were used for individuals who did not complete followup surveys. A cost-effectiveness analysis was also completed. Cost data were compiled on counseling, program development, materials/supplies and overhead. Counseling cost was derived from time spent in encounters between the participants and the counselors and the salary (including fringe benefits) of an average CHP counselor employed. The times of 30 actual intervention calls and letters were recorded and an average counseling time for each intervention type was computed. A time estimate was attached to each encounter call and total counseling time per participant over the 24 months was computed. Development cost was based on staff time and material for intervention development. The usual care group was assigned zero on this component since the counseling International Journal of Obesity Mail and phone interventions for weight loss in a managed-care setting NE Sherwood et al 1568 programs utilized by this group were previously developed by CHP. Overhead costs included the operating cost of the computer system, office space rental, and phone charges. A cost-effectiveness ratio was computed for each group to provide a measure of how efficiently the interventions produced a kilogram of weight loss. Figure 2 provides an overview of weight change over time by treatment group status, including 6 and 12 months outcomes presented in previously published work.28 Table 2 presents weight-change outcomes at 18- and 24-month follow-up. Although on average participants across the study conditions lost weight (i.e., weight loss in each group was significantly different from 0), no statistically significant group differences in weight change were observed at 18 months (Cohen’s d, Mail vs UC ¼ 0.03; Phone vs UC ¼ 0.04) – or 24-months (Cohen’s d, Mail vs UC ¼ 0.01; Phone vs UC ¼ 0.03). At 18-months, about 24% of participants lost 5% of their body weight, with almost 10% losing 10% of their body weight. At 24-months, about 13% of participants lost 5% of their body weight, with about 5% losing 10% of their body weight. No adverse events and/or side effects were observed as a result of intervention participation. Table 3 shows the proportion of individuals in the mail and phone groups who activated treatment. Activation was higher in the mail (88%) compared to the phone group (69%; w2 ¼ 62.97, Po0.001). Among treatment activators, participation was higher in the phone compared to the mail condition. The average number of treatment lessons completed was 7.2 in the phone group and 2.3 in the mail group through 24 months (t ¼ 20.60, Po0.001). Over half of activated phone participants completed the program, whereas just over 10% in the mail group completed the Results A flowchart of study participation according to CONSORT guidelines is shown in Figure 129,30 and study sample descriptive information is shown in Table 1.28 The majority of participants were Caucasian (n ¼ 1639, 91%), welleducated (n ¼ 899, 50% college or graduate degree), female (n ¼ 1293, 72%), middle-aged (mean age ¼ 50 years, s.d. ¼ 12) adults. Average BMI was about 33.5 kg/m2. About 30% met the prevailing definition for overweight, 40% for Class I obesity, 20% for Class II obesity, and 10% for Class III obesity. A substantial number of participants reported taking medication for diabetes (5.9%), depression (13.9%), or cardiovascular disease (CVD) related problems (e.g., high blood pressure) (27.3%). Treatment groups differed significantly on one baseline variable. Phone group participants were more likely to report taking depression medication than those in the other groups (Po0.013). Assessed for eligibility (n=3294) Enrollment Excluded (n=1493) Did not meet inclusion criteria (n=1091) Refused to participate (n=60) Other reasons (e.g., clinic visit no show) (n=342) Randomization Mail (n=600) Weigh-To-Be Course Activated intervention (n=528) Activated, 0 sessions completed (n=260) Completed 1-9 sessions (n=206) Completed all 10 sessions (n=62) Did not activate intervention (n=72) CHP Weight-Related Encounters 0-1 Counseling Encounters (n=430) 2-9 Counseling Encounters (n=115) 10+ Counseling Encounters (n=55) Phone (n=601) Weigh-To-Be Course Activated intervention (n=416) Activated, 0 sessions completed (n=24) Completed 1-9 sessions (n=165) Completed all 10 sessions (n=227) Did not activate intervention (n=185) CHP Weight-Related Encounters 0-1 Counseling Encounters (n=218) 2-9 Counseling Encounters (n=138) 10+ Counseling Encounters (n=245) Usual Care (n=600) Weigh-To-Be Course Activated intervention NA Activated, 0 sessions completed NA Completed 1-9 sessions NA Completed all 10 sessions NA Did not activate intervention NA CHP Weight-Related Encounters 0-2 Counseling Encounters (n=486) 2-9 Counseling Encounters (n=54) 10+ Counseling Encounters (n=60) Follow-Up Mail Lost to follow-up Quit study prior to 24 mos (n=85) Lost to follow-up at 24 mos (n=134) 24 Month data available for analysis Measured weight & survey data (n=325) Survey data only (n=56) Figure 1 Weigh-To-Be (WTB) CONSORT guideline flowchart. International Journal of Obesity Phone Lost to follow-up Quit study prior to 24 mos (n=68) Lost to follow-up at 24 mos (n=128) 24 Month data available for analysis Measured weight & survey data (n=341) Survey data only (n=63) Usual Care Lost to follow-up Quit study prior to 24 mos (n=84) Lost to follow-up at 24 mos (n=106) 24 Month data available for analysis Measured weight & survey data (n=337) Survey data only (n=73) Mail and phone interventions for weight loss in a managed-care setting NE Sherwood et al 1569 Table 1 Description of study population at baseline Mail (n ¼ 600) %/mean (s.e.) Phone (n ¼ 601) %/mean (s.e.) Usual care (n ¼ 600) %/mean (s.e.) P-value 69.0 73.5 72.8 0.170 50.6 (0.5) 50.7 (0.5) 50.8 (0.5) 0.943 Education: High school or less Some college/vocational training College or grad degree 12.2 39.6 48.3 11.7 37.3 51.1 13.2 36.3 50.5 Ethnicity (% white) 90.0 92.2 91.0 Marital status: Married Separated, divorced, or widowed Never married 70.8 20.8 8.3 68.2 20.0 11.8 71.8 16.5 11.7 9.0 9.0 7.8 0.708 34.1 (0.2) 33.5 (0.2) 34.0 (0.2) 0.435 Weight status (BMI) Overweight (25–29.9) Obese class I (30–34.9) Obese class II (35–39.9) Obese class III (X40) Ever dieted (% yes) 25.3 39.0 21.3 14.3 85.8 27.8 35.8 19.0 17.3 87.0 27.4 39.1 18.5 15.0 84.7 0.525 Formal weight-loss program in past 2 years (% yes) 26.2 30.8 30.8 0.125 Current medication (% yes) Diabetes Depression CVD-related 4.7 12.5 26.0 6.5 18.0 27.6 5.3 11.2 28.3 0.374 0.002 0.649 Gender (% female) Age (year) 0.737 0.214 Current smoker (% yes) 2 BMI (kg/m ) 0.525 0 -0.5 Weight change -1 -1.5 -2 -2.5 m os 24 m os 18 m os 12 os m 6 el in e -3 Ba s 0.900 Assessment T i me Mail Phone Usual Care Figure 2 Weight change over time among Weigh-To-Be (WTB) participants by treatment group. program (w2 ¼ 294.21, Po0.001). The phone course took fewer days to complete (phone average, 158 days; mail average, 263). Table 3 also shows the predictive value of study activation and level of program completion with respect to 18- and 24-month weight loss. Study activation alone was not a strong predictor of weight-loss. Difference in weight loss by this measure was significant only at 18months in the phone intervention (Cohen’s d ¼ 0.08). Number of completed lessons was a better predictor of outcomes than treatment activation. Observed weight losses were consistently higher in those who completed more lessons in the mail condition at both 18 months (Cohen’s d, 1–9 vs 0 lessons ¼ 0.11; 10 vs 0 lessons ¼ 0.34) and 24 months (Cohen’s d, 1–9 vs 0 lessons ¼ 0.04; 10 vs 0 lessons ¼ 0.28). Participation was associated significantly with weight loss at 18-months in the phone condition (Cohen’s d, 1–9 vs 0 lessons ¼ 0.06; 10 vs 0 lessons ¼ 0.18); however, no significant weight change differences by level of lesson completion were observed at 24-months (Cohen’s d, 1–9 vs lessons ¼ 0.02; 10 vs 0 lessons ¼ 0.03). In addition to the WTB course, participants across the three study conditions had the opportunity to participate in CHP weight management and related programs. The average number of classes taken by participants in the mail, phone, and usual care conditions were 1.1 (s.d. ¼ 0.6), 1.2 (s.d. ¼ 1.1), and 0.5 (s.d. ¼ 0.7), respectively. About a third of usual care participants (34.3%, n ¼ 394) were active in International Journal of Obesity Mail and phone interventions for weight loss in a managed-care setting NE Sherwood et al 1570 Table 2 Weight-change outcomes at 18 and 24 months by treatment group Mail %/mean (s.e.) Phone %/mean (s.e.) Usual care %/mean (s.e.) P-value 18-month weight outcomesa Weight changeb (kg) Adjusted weight changec (kg) 5% weight lossb (% yes) 10% weight lossb (% yes) n ¼ 600 2.27 (0.24) 2.24 (0.24) 23.67 9.67 n ¼ 601 2.35 (0.24) 2.39 (0.24) 25.33 9.50 n ¼ 600 1.91 (0.24) 1.90 (0.24) 22.67 8.17 0.390 0.348 0.549 0.613 24-month weight outcomes Weight changeb (kg) Adjusted weight changec (kg) 5% weight lossb (% yes) 10% weight lossb (% yes) n ¼ 600 0.73 (0.22) 0.70 (0.22) 13.33 4.83 n ¼ 601 0.93 (0.22) 0.96 (0.22) 14.50 5.33 n ¼ 600 0.59 (0.22) 0.59(0.22) 12.17 4.33 0.552 0.475 0.493 0.722 Note: Means with unshared superscripts were significantly different in pair-wise post hoc comparisons (Pp0.05). a18-month weight data is based on self-report by participants. bAnalysis controlled for baseline body weight (kg). cAnalysis controlled for baseline weight and significant predictors of 18- and 24-month weight change: sex, age, formal weight-loss program participation, and depression medication. Table 3 Program participation and weight loss by treatment group Mail condition %/mean (s.d.) Participation, 24 months: Activating treatment (%) Number of sessions completed Completed 10 sessions (% yes) (Of those enrolled % yes) Weight loss, 18 months: Not activated Activated Weight loss, 24 months: Not activated Activated Weight loss, 18 months: Not activating or 0 lessons Completed 1–9 lessons Completed 10 lessons Weight loss, 24 months: Not activating or 0 lessons Completed 1–9 lessons Completed 10 lessons 88.0 (n ¼ 528) 2.3 (3.5) 10.3 ( n ¼ 62) 11.7 Phone condition %/mean (s.d.) 69.2 (n ¼ 416) 7.2 (3.7) 38.4 (n ¼ 231) 55.5 1.5 (0.7)(n ¼ 72) 1.6 (0.5)(n ¼ 187) 2.4 (0.2)(n ¼ 528) 2.7 (0.3)(n ¼ 414) Po0.178 Po0.030 0.6 (0.6)(n ¼ 72) 0.9 (0.4)(n ¼ 186) 0.8 (0.2)(n ¼ 528) 1.0 (0.3)(n ¼ 415) Po0.818 Po0.900 1.5a (0.3)(n ¼ 332) 1.4a (0.4)(n ¼ 209) 2.7b (0.4)(n ¼ 206) 2.1a (0.5)(n ¼ 165) 5.5c (0.7)(n ¼ 62) 3.5b (0.4)(n ¼ 227) Po0.001 Po0.002 0.3a (0.3)(n ¼ 332) 0.8 (0.4)(n ¼ 208) 0.7a (0.3)(n ¼ 206) 1.0 (0.4)(n ¼ 163) 3.3b (0.6)(n ¼ 62) 1.1 (0.4)(n ¼ 230) Po0.001 Po0.845 ences were observed between usual care group participants by participation status. Data were also analyzed by the number of weight-related encounters with CHP. As shown in Table 4, number of CHP encounters was significantly associated with 18-month weight change in the mail and phone conditions. Mail participants with ten or more encounters lost more weight than those with fewer encounters (Cohen’s d, 2–9 vs 0-1 encounters ¼ 0.07; 10 þ vs 0–1 encounters ¼ 0.23). Phone participants with 10 or more encounters lost more weight than those with one or fewer encounters (Cohen’s d, 2–9 vs 0–1 encounters ¼ 0.08; 10 þ vs 0–1 encounters ¼ 0.16). Encounter number was a significant predictor of weight change at 24-months among mail participants only. Mail participants with two or more encounters lost more weight than those with one or fewer encounters (Cohen’s d, 2–9 vs 0–1 encounters ¼ 0.14; 10 þ vs 0–1 encounters ¼ 0.23). Table 5 presents data from the cost-effectiveness analyses and show that counseling time was the largest cost component, accounting for 54.9, 73.2 and 84.4% of total expenditure in mail, phone and usual care groups, respectively. Program development costs were the second largest expenditure. The cost-effectiveness ratios show that phone counseling appeared to be least efficient at a price tag of $132 in producing 1 kg of weight loss while mail and usual care group achieved similar efficiency of $72 per 1 kg weight loss. Note: Means with unshared superscripts were significantly different in pairwise post hoc comparisons (Pp0.05). Discussion CHP classes; among those who were active in classes, the average number of classes taken was 1.33 (s.d. ¼ 0.04). Usual care group participants active in classes lost more weight at 18-months compared to inactive participants (Active ¼ 2.6 (s.d. ¼ 7.9); Not Active ¼ 1.5 (s.d. ¼ 4.3), Po0.05, Cohen’s d ¼ 0.09). No significant 24-month weight change differInternational Journal of Obesity This study was the first large scale randomized trial evaluating weight loss interventions on a large scale in a real world health care delivery setting. We deliberately chose to test mail and phone-based programs that might be affordable in such a setting and overall we conclude that Mail and phone interventions for weight loss in a managed-care setting NE Sherwood et al 1571 Table 4 Center for Health Promotion encounters and weight loss by treatment group – participation, 18 and 24 months Mail Phone Usual care All weight-related encounters (including WTB encounters), 18 months 0–1 1.89a (0.26)(n ¼ 430) 2–9 2.68a (0.51)(n ¼ 115) 10+ 4.48b (0.74)(n ¼ 55) Po0.003 1.36a (0.42)(n ¼ 218) 2.35a,b (0.52)(n ¼ 138) 3.30b (0.39)(n ¼ 245) Po0.003 1.72 (0.28)(n ¼ 486) 1.98 (0.84)(n ¼ 54) 2.96 (0.80)(n ¼ 60) Po0.347 All weight-related encounters (including WTB encounters), 24 months 0–1 0.27a (0.24)(n ¼ 430) 2–9 1.69b (0.47)(n ¼ 115) 10+ 2.34b (0.49)(n ¼ 55) Po0.001 0.69 (0.37)(n ¼ 218) 0.86 (0.46)(n ¼ 138) 1.23 (0.34)(n ¼ 245) Po0.553 0.47 (0.33)(n ¼ 486) 0.18 (0.47)(n ¼ 54) 1.65 (0.69)(n ¼ 60) Po0.275 Note: Means with unshared superscripts were significantly different in pair-wise post hoc comparisons (Pp0.05). Table 5 Costs, effects, cost-effectiveness ratios and incremental cost-effectiveness ratios for the weigh-to-be study Mail (n ¼ 600) Phone (n ¼ 601) Usual care (n ¼ 600) Total (n ¼ 1801) Costs Counseling/subject Program development/subject Materials and supplies/subject Overhead/subject Total cost/subject $27.71 $11.98 $5.65 $5.11 $50.45 $93.28 $11.98 $4.92 $17.21 $127.39 $35.61 $0.00 $0.00 $6.57 $42.18 $52.23 $7.99 $3.53 $9.64 $73.38 Effects 24-month weight outcomes Adjusted weight change (kg) 0.70 (1.13, 0.27)a 0.96 (1.39,0.53) 0.59 (1.02,0.16) $72.08 $132.70 $71.50 Cost-effectiveness ratios Cost/weight loss of 1 kg a The numbers in parentheses represent 95% confidence interval of the estimated parameters. delivering mail and phone interventions are potentially feasible in this regard. Recruitment and participation rates were acceptable and program implementation costs under $200.00 per person seem reasonable, particularly in comparison to recent estimates of the economic costs of obesity.31 Examination of relationships between BMI and health care costs has shown that annual medical charges are about $214.00 greater for individuals with a BMI between 30 and 34 kg/m2 compared to individuals with a BMI in the normal range (o25 kg/m2). Data also suggest, not surprisingly, that outcome is dependent on engagement level. At 18 months, participants who were more active in both the phone and mail conditions lost more weight compared to less active participants. Interestingly, at 24 months, mail participants who were more active in treatment were more successful, whereas there was no similar effect for phone participants. These data suggest that mail completers may have been more self-motivated for weight loss. Despite room for optimism, our data clearly show that weight-loss efficacy needs improvement. At best, the 24 month results show that the interventions, including those that usual care participants took part in, served as effective weight gain prevention as opposed to weight loss programs. Weight loss results were more promising at 6 months than later.28 In examining the timing of the WTB course and other weight-related encounters, we observed that the majority of counseling contacts occur during the first 6–12 months of the study, so failure to detect significant group differences at the later time points is not completely surprising. An additional factor in the interpretation of these findings is the fact that the ‘usual care’ was unusually potent in this study. The CHP is unique in its offering of relatively low cost weight management services to members. Many members, however, are probably not aware of these services and thus don’t use them. Usual care participants in this study were explicitly made aware of these member services and participated in them at relatively high rates, about 1 person in 3. As a result, significant weight loss observed in our ‘control’ group may have lessened our ability to detect effects in our active treatments. Considering our intervention experience overall, we believe that the interventions could be considerably strengthened by implementation of stronger intervention messages and engagement strategies for keeping people International Journal of Obesity Mail and phone interventions for weight loss in a managed-care setting NE Sherwood et al 1572 involved in weight loss over longer periods of time. The Diabetes Prevention Program (DPP) provides an excellent model for both improving the potency of the intervention messages and engaging participants long term.32 Examination of these results and lessons learned from the DPP suggest several strategies to improve outcomes. First, in this trial, participants in the phone and mail conditions selfinitiated treatment so that the attractiveness of each format could be evaluated. Future interventions should include more active outreach efforts to engage participants. A second strategy is the incorporation of stronger behavioral messages and strategies. Our previous work and the work of others, shows that participants who more actively self-monitor their behavior and weight are more successful.33 Weight selfmonitoring was not strongly encouraged in WTB, but future interventions should promote this behavior. Dietary and activity goal-setting should also be strengthened. As suggested by the DPP, strategies such as motivational campaigns and a ‘tool box’ should be used to provide extra support to struggling participants and novelty to keep participants engaged longer.28 Additionally, the use of incentives for program participation should be explored (e.g., reimbursement of program costs and/or lower insurance premium for program participation). To summarize, cost-effective approaches to weight loss and maintenance are needed for use in health care settings. Phone and mail-based options are viable options in terms of cost and logistics, but weight loss outcomes were less than desired. Strengthened behavioral messages and engagement strategies are needed to increase the magnitude of weight losses and their maintenance over time. References 1 Flegal KM, Carroll MD, Kuczmarski RJ, Johnson CL. Overweight and obesity in the United States: prevalence and trends, 1960– 1994. 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