Betty M. Kennedy

Comparison of Strategies for Sustaining Weight Loss: The Weight Loss Maintenance Randomized Controlled Trial

CONTEXT Behavioral weight loss interventions achieve short-term success, but re-gain is common. OBJECTIVE To compare 2 weight loss maintenance interventions with a self-directed control group. DESIGN, SETTING, AND PARTICIPANTS Two-phase trial in which 1032 overweight or obese adults (38% African American, 63% women) with hypertension, dyslipidemia, or both who had lost at least 4 kg during a 6-month weight loss program (phase 1) were randomized to a weight-loss maintenance intervention (phase 2). Enrollment at 4 academic centers occurred August 2003-July 2004 and randomization, February-December 2004. Data collection was completed in June 2007. INTERVENTIONS After the phase 1 weight-loss program, participants were randomized to one of the following groups for 30 months: monthly personal contact, unlimited access to an interactive technology-based intervention, or self-directed control. Main Outcome Changes in weight from randomization. RESULTS Mean entry weight was 96.7 kg. During the initial 6-month program, mean weight loss was 8.5 kg. After randomization, weight regain occurred. Participants in the personal-contact group regained less weight (4.0 kg) than those in the self-directed group (5.5 kg; mean difference at 30 months, -1.5 kg; 95% confidence interval [CI], -2.4 to -0.6 kg; P = .001). At 30 months, weight regain did not differ between the interactive technology-based (5.2 kg) and self-directed groups (5.5 kg; mean difference -0.3 kg; 95% CI, -1.2 to 0.6 kg; P = .51); however, weight regain was lower in the interactive technology-based than in the self-directed group at 18 months (mean difference, -1.1 kg; 95% CI, -1.9 to -0.4 kg; P = .003) and at 24 months (mean difference, -0.9 kg; 95% CI, -1.7 to -0.02 kg; P = .04). At 30 months, the difference between the personal-contact and interactive technology-based group was -1.2 kg (95% CI -2.1 to -0.3; P = .008). Effects did not differ significantly by sex, race, age, and body mass index subgroups. Overall, 71% of study participants remained below entry weight. CONCLUSIONS The majority of individuals who successfully completed an initial behavioral weight loss program maintained a weight below their initial level. Monthly brief personal contact provided modest benefit in sustaining weight loss, whereas an interactive technology-based intervention provided early but transient benefit. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00054925.

Associations of Internet Website Use With Weight Change in a Long-term Weight Loss Maintenance Program

Background The Weight Loss Maintenance Trial (WLM) compared two long-term weight-maintenance interventions, a personal contact arm and an Internet arm, with a no-treatment control after an initial six-month Phase I weight loss program. The Internet arm focused on use of an interactive website for support of long-term weight maintenance. There is limited information about patterns of website use and specific components of an interactive website that might help promote maintenance of weight loss. Objective This paper presents a secondary analysis of the subset of participants in the Internet arm and focuses on website use patterns and features associated with long-term weight maintenance. Methods Adults at risk for cardiovascular disease (CVD) who lost at least 4 kilograms in an initial 20-week group-based, behavioral weight-loss program were trained to use an interactive website for weight loss maintenance. Of the 348 participants, 37% were male and 38% were African American. Mean weight loss was 8.6 kilograms. Participants were encouraged to log in at least weekly and enter a current weight for the 30-month study period. The website contained features that encouraged setting short-term goals, creating action plans, and reinforcing self-management habits. The website also included motivational modules, daily tips, and tailored messages. Based on log-in and weight-entry frequency, we divided participants into three website use categories: consistent, some, and minimal. Results Participants in the consistent user group (n = 212) were more likely to be older (P = .002), other than African American (P = .02), and more educated (P = .01). While there was no significant difference between website use categories in the amount of Phase I change in body weight (P = .45) or income (P = .78), minimal website users (n = 75) were significantly more likely to have attended fewer Phase I sessions (P = .001) and had a higher initial body mass index (BMI) (P < .001). After adjusting for baseline characteristics including initial BMI, variables most associated with less weight regain included: number of log-ins (P = .001), minutes on the website (P < .001), number of weight entries (P = .002), number of exercise entries (P < .001), and sessions with additional use of website features after weight entry (P = .002). Conclusion Participants defined as consistent website users of an interactive behavioral website designed to promote maintenance of weight loss were more successful at maintaining long-term weight loss. Trial Registration NCT00054925; http://clinicaltrials.gov/ct2/show/NCT00054925 (Archived by WebCite at http://www.webcitation.org/5rC7523ue)

Predictors of long-term weight loss in adults with modest initial weight loss, by sex and race.

Effective weight management interventions could reduce race—sex disparities in cardiovascular disease (CVD), yet little is known about factors associated with successful weight loss maintenance in race—sex subgroups. In the Weight Loss Maintenance trial (WLM), overweight/obese (BMI 25–45 kg/m2) adults who lost ≥4 kg in a 6‐month behavioral weight loss intervention (phase I) were randomized into one of three 30‐month maintenance interventions (phase II). To investigate predictors in subgroups, randomized groups were combined for this analysis. Of 1,685 phase I participants, 1,032 (61%) entered phase II, including 12% black men (BM), 26% black women (BW), 25% white men (WM), and 37% white women (WW). Weight change over the 36‐month study ranged from −2.3% (95% confidence interval = −3.1 to −1.5%) in BW to −4.5% (95% confidence interval = −5.7 to −4.0%) in WM, the result of differential weight loss during phase I. Within race, men lost significantly more weight than women, but within sex group, weight loss did not differ significantly between races. Although participants regained weight during phase II, regain did not differ by race—sex group, and mean weight at the end of the study was significantly lower than phase I entry weight for each subgroup. In regression models, phase I weight loss predicted overall 36‐month weight loss in all race—sex groups. Healthy dietary pattern at entry, improvement in dietary pattern, or both were predictive in three of four race—sex groups. Few other variables other than initial weight loss and dietary pattern were predictive. Future research should identify additional modifiable influences on long‐term maintenance after a modest weight loss.

Overall and minority-focused recruitment strategies in the PREMIER multicenter trial of lifestyle interventions for blood pressure control

Recruitment strategies employed by four clinical centers across the US and a coordinating center were examined to identify successful overall and minority-focused recruitment strategies for the PREMIER multicenter trial of lifestyle changes for blood pressure control. The goal was to recruit 800 adults (40% African Americans) with systolic blood pressure of 120-159 mm Hg and diastolic of 80-95 mm Hg, not taking antihypertensive medication. Clinical centers used combinations of mass distribution of brochures, mass media, email distribution lists, screening events, and a national website. Culturally appropriate strategies for African Americans were designed by a Minority Implementation (MI) committee. Diversity training was provided for study staff, and African Americans were included in the study design process. Main recruitment outcomes were number overall and number of African Americans recruited by each strategy. Of the 810 randomized PREMIER participants, 279 (34%) were African American with site-specific percentages of 56%, 46%, 27%, and 8%. Of African Americans recruited, 151 (54%) were from mass distribution of brochures (mailed letter, flyer included in Val-Pak coupons, or other), 66 (24%) from mass media (printed article, radio, TV story or ads, 52 (19%) from word of mouth, and 10 (3%) from email/website and screening events combined. Yields for Non-Hispanic Whites were 364 (69%) from brochures, 71 (13%) from mass media, 49 (9%) from word of mouth and 47 (9%) from email/website and screening events. Mass distribution of brochures was relatively more effective with Non-Hispanic Whites, while African Americans responded relatively better to other recruitment strategies.

Effect of Group Racial Composition on Weight Loss in African Americans

Objective: We do not know how racial composition of a group influences behavior change for African Americans (AAs) in group‐based weight loss programs. We tested the hypothesis that AA who participate in all AA weight loss intervention groups will lose more weight than AA who participate in mixed race groups.

Recruitment and Baseline Characteristics of Participants in the Dietary Approaches to Stop Hypertension Trial

Dietary Approaches to Stop Hypertension (DASH) was a randomized, multicenter feeding study designed to assess the effects of modifying dietary patterns on blood pressure. Among the most challenging aspects of conducting the DASH trial was the recruitment of participants at the 4 clinical centers. As part of the recruitment drive, 347,500 brochures were mailed, 250,500 coupons were distributed in coupon packs, 114 advertisements were published in newspapers or bulletins, 140 radio and 74 television advertisements were broadcast, and 68 screening events and presentations were conducted. These efforts yielded a total of 459 enrolled participants, ahead of schedule. The most common source of participants was mass mailing of individual brochures (n = 194, 42.3%), followed by word-of-mouth (n = 82, 17.8%), and then other types of mass mailing (n = 44, 9.6%). Recruitment of minority participants followed a similar pattern. Among the 3,192 persons attending the first in-person screening visit, the major reason for nonenrollment was low blood pressure (56%) rather than a diet-related factor. The study population was demographically heterogeneous (49% women, 60% African American, 48% married, and 77% employed full-time). On average, the diet of participants before the DASH feeding study was more similar to the trial control diet than to the combination diet, which reduced blood pressure more effectively. In summary, recruitment of a heterogeneous study population that includes a substantial number of minority participants is a feasible undertaking. However, the effort is considerable and requires a major commitment of resources.

Behavioral transitions and weight change patterns within the PREMIER trial.

Little is known about the transition in behaviors from short‐term weight loss to maintenance of weight loss. We wanted to determine how short‐term and long‐term weight loss and patterns of weight change were associated with intervention behavioral targets. This analysis includes overweight/obese participants in active treatment (n = 507) from the previously published PREMIER trial, an 18‐month, multicomponent lifestyle intervention for blood pressure reduction, including 33 intervention sessions and recommendations to self‐monitor food intake and physical activity daily. Associations between behaviors (attendance, recorded days/week of physical activity, food records/week) and weight loss of ≥5% at 6 and 18 months were examined using logistic regression. We characterized the sample using 5 weight change categories (weight gained, weight stable, weight loss then relapse, late weight loss, and weight loss then maintenance) and analyzed adherence to the behaviors for each category, comparing means with ANOVA. Participants lost an average of 5.3 ± 5.6 kg at 6 months and 4.0 ± 6.7 kg (4.96% of body weight) by 18 months. Higher levels of attendance, food record completion, and recorded days/week of physical activity were associated with increasing odds of achieving 5% weight loss. All weight change groups had declines in the behaviors over time; however, compared to the other four groups, the weight loss/maintenance group (n = 154) had statistically less significant decline in number of food records/week (48%), recorded days/week of physical activity (41.7%), and intervention sessions attended (12.8%) through 18 months. Behaviors associated with short‐term weight loss continue to be associated with long‐term weight loss, albeit at lower frequencies. Minimizing the decline in these behaviors may be important in achieving long‐term weight loss.

Socioeconomic Status and Health Disparity in the United States

Abstract Low socioeconomic status (SES) has been associated with high rates of many chronic diseases. This study was a cluster analysis of data from 9,830 adults in the 1994-96 Continuing Survey of Food Intakes by the Individuals (1994-96 CSFII) in order to characterize more fully the biologic and social factors that might be associated with chronic diseases. The study employed cluster analysis to define three SES groups (low, middle, and high) based on income, education, age, gender, and race. A significant increase was found in self-reported diabetes, hypertension, heart disease, obesity, and stroke across these groups, being highest in the lowest SES group. Results revealed that health disparity in the U.S. may be substantial, with some population groups bearing a disproportionate burden of chronic diseases.

Capacity Building for Health Through Community-Based Participatory Nutrition Intervention Research in Rural Communities

Since its inception, capacity building has been a stated goal of the Delta Nutrition Intervention Research Initiative, a tri-state collaboration in the Lower Mississippi Delta to address high rates of chronic disease. Textual analysis of project documents identifies and describes strategies carried out to foster capacity building. Strategies to build community capacity include fostering participation, cultivating leadership opportunities, training community members as co-researchers, securing community resources, and implementing the intervention together. Incorporating capacity-building approaches in health promotion and nutrition-intervention programming in rural communities provides a means to enhance potential for sustainability of health outcomes and developed effectiveness.

Challenges to recruitment and retention of African Americans in the gene-environment trial of response to dietary interventions (GET READI) for heart health

In this paper, challenges to recruiting African Americans specifically for a dietary feeding trial are examined, learning experiences gained and suggestions to overcome these challenges in future trials are discussed. A total of 333 individuals were randomized in the trial and 234 (167 sibling pairs and 67 parents/siblings) completed the dietary intervention and required DNA blood sampling for genetic analysis. The trial used multiple strategies for recruitment. Hand distributed letters and flyers through mass distribution at various churches resulted in the largest number (n = 153, 46%) of African Americans in the trial. Word of mouth accounted for the second largest number (n = 120, 36%) and included prior study participants. These two recruitment sources represented 82% (n = 273) of the total number of individuals randomized in GET READI. The remaining 18% (n = 60) consisted of a combination of sources including printed message on check stubs, newspaper articles, radio and TV appearances, screening events and presentations. Though challenging, the recruitment efforts for GET READI produced a significant number of African American participants despite the inability to complete the trial as planned because of low recruitment yields. Nevertheless, the recruitment process produced substantial numbers that successfully completed all study requirements.