Weight Loss Maintenance (WLM)

HLB00841111a

WLM

False

Released

True

True

Coded

False

Clinical Trial

Open BioLINCC Study

Adult

Behavioral: Personal contact (PC)Behavioral: Interactive technology (IT)

2011-08-02

2011-08-02

2010-06-08

None

2003 - 2009

DCVS

Heart

non-HIV

non-COVID

16736

0

No

No

No

Yes

Yes, For Some Specimens

Yes

Consent for non-genetic use of biospecimens is restricted based on area of research, which includes (1) obesity, heart disease prevention, exercise and nutrition, (2) weight control and its consequences, and (3) weight, cardiovascular disease prevention, exercise, or nutrition.

A subset of specimens have been consented for genetic use research, with tiers on area of research for (1) weight control and its consequences, (2) weight, cardiovascular disease prevention, exercise, or nutrition, (3) any health condition.

Cardiovascular Diseases
Diabetes Mellitus, Non-insulin Dependent
Heart Diseases
Hypertension
Obesity

To compare the long-term effects of two weight loss maintenance intervention groups, one receiving behavioral intervention through personal counseling and the other receiving behavioral intervention through web-based individually tailored interactive technology, versus a self-directed/usual care control group.

Nearly two-thirds of US adults are overweight or obese and together overweight and obesity are the second leading cause of preventable death, primarily through effects on cardiovascular disease (CVD) risk factors (hypertension, dyslipidemia, and type 2 diabetes). Weight loss improves these risk factors, and evidence suggests that benefits persist as long as weight loss is maintained. Even with the potential for health benefits of sustained weight loss, there is little evidence, especially from clinical trials, on how to maintain weight loss. In fact, very few trials have explicitly tested alternative strategies to sustain weight loss, and few weight loss studies have implemented interventions for longer than 18 months. The Weight Loss Maintenance trial (WLM) tests strategies for sustaining weight loss after initial clinically significant weight loss has been achieved. WLM participants were a diverse population at high CVD risk, populations at highest risk of obesity-related consequences and therefore with the greatest potential to benefit from sustained weight loss.

The two-phase trial included 1032 overweight or obese adults (38% African American, 63% women) from four clinical centers: Duke University, Johns Hopkins University, Pennington Biomedical Research Center, and the Kaiser Permanente Center for Health Research. To be included into phase 1 of the study, participants were required to have a body mass index (BMI), between 25 and 45 kg/m^2; to be taking medication for hypertension, dyslipidemia, or both; to have no active CVD (those with a positive Rose angina questionnaire or a CVD event no less than 12 months before study entry and a negative stress test result could join the study with permission from their physician); access to a telephone and to the Internet; and to keep a food diary for 5 days during the screening. Major exclusion criteria for phase 1 were medication-treated diabetes mellitus, a recent cardiovascular event or other medical or psychiatric conditions that would preclude full participation in the study, weight loss of more than 9 kg in the last 3 months, recent use of weight loss medications, or prior weight loss surgery. The primary criterion for randomization into the study's second phase was weight loss of at least 4 kg during the first phase.

Participants were enrolled in 2 phases of the clinical trial: phase 1 was a 6-month nonrandomized initial weight loss intervention for all participants to help them reduce caloric intake, promote a DASH (Dietary Approaches to Stop Hypertension) dietary pattern, and increase moderate-intensity physical activity to lose >4 kg of body weight. During this phase, participants were offered 20 group weight loss sessions, approximately weekly, over 6 months. Those who lost >4 kg of body weight during phase I were eligible for phase II. Phase II participants were randomized to receive either one of two weight-maintenance strategies (personal contact or interactive technology) or a self-directed control condition. Participants randomized to personal contact (PC) had monthly contact, mostly by phone, with a trained interventionist, during which behavioral intervention was continued. Participants randomized to interactive technology (IT) were trained to use an interactive website for weight loss maintenance. 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, the participants were divided into three website use categories: consistent, some, and minimal.

The majority of individuals who successfully completed an initial behavioral weight loss program, lost at least 4 kg, and were randomized to phase 2 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.

Svetkey LP, Ard JD, Stevens VJ, Loria CM, Young DY, Hollis JF, Appel LJ, Brantley PJ, Kennedy BM, Kumanyika SK, Batch BC, Corsino L, Lien LF, and Vollmer WM, for the Weight Loss Maintenance Collaborative Research Group. Predictors of Long-Term Weight Loss in Adults with Modest Initial Weight Loss, by Sex and Race. Obesity, 2012, 20: 1820-1828. https://doi.org/10.1038/oby.2011.88

Funk KL, Stevens VJ, Bauck A, Brantley PJ, Hornbrook M, Jerome GJ, Myers VH, Appel L. Development and Implementation of a Tailored Self-Assessment Tool in an Internet-Based Weight Loss Maintenance Program. Clinical Practice & Epidemiology in Mental Health, 2011 Mar 4, 67-73

Samuel-Hodge CD, Gizlice Z, Cai J, Brantley PJ, Ard JD, Svetkey LP. Family Functioning and Weight Loss in a Sample of African Americans and Whites. Ann Behav Med. 2010 Dec;40(3):294-301.

Maruthur NM, Vollmer WM, Clark JM, Jerome GJ, Lien LF, Loria CM, Appel LJ. Measurement of Weight in Clinical Trials: Is One Day Enough?, Journal of Obesity, vol. 2010, Article ID 413407, 3 pages, 2010. doi:10.1155/2010/413407

Funk KL, Stevens VJ, Appel LJ, Bauck A, Brantley PJ, Champagne CM, Coughlin JW, Dalcin AT, Harvey-Berino J, Hollis JF, Jerome GJ, Kennedy BM, Lien LF, Myers VH, Samuel-Hodge C, Svetkey LP, Vollmer WM. Associations of Internet Website Use with Weight Change in a Long-term Weight Loss Maintenance Program. J Med Internet Res. 2010 Jul 27;12(3):e29.

Young D, Jerome GJ, Chen C, Laferriere D, Vollmer WM. Patterns of Physical Activity Among Overweight and Obese Adults. Preventing Chronic Disease; 2009 Jul;6(3):A89. Epub 2009 Jun 15.

Meenan R, Stevens VJ, Funk K, Bauck A, Jerome GJ, Lien LF, Appel LJ, Brantley PJ, Svetkey LP. Development and Implementation Cost Analysis of Telephone- and Internet-based Interventions for the Maintenance of Weight Loss. International Journal of Technology Assessment in Health Care; 2009 Jul; 25(3): 400-10.

Chen C, Jerome GJ, Laferriere D, Young DR, Vollmer WM. Procedures Used to Standardize Data Collected by RT3 Triaxial Accelerometers in a Large-Scale Weight-Loss Trial. J Phys Act Health. 2009 May;6(3):354-9. PubMed PMID: 19564665.

Newgard CB, An J, Bain JR, Muehlbauer MJ, Stevens RD, Lien LF, Haqq AM, Shah SH, Arlotto M, Slentz CA, Rochon J. Gallup D, Ilkayeva O, Wenner BR, Yancy WE, Eisenson H, Musante G, Surwit R, Millington DS, Butler MD, Svetkey LP. A Branched-Chain Amino Acid-Related Metabolic Signature that Differentiates Obese and Lean Humans and Contributes to Insulin Resistance. Cell Metabolism. 2009 Apr;9(4):311-26.

Lien LF, Haqq AM, Arlotto M, Slentz CA, Muehlbauer MJ, McMahon RL, Rochon J, Gallup D, Bain JR, Ilkayeva O, Wenner B, Stevens RD, Millington DS, Butler MD, Newgard CB, Svetkey LP. The STEDMAN project: biophysical, biochemical and metabolic effects of a behavioral weight loss intervention during weight loss, maintenance, and regain. OMICS. 2009 Feb;13(1):21-35.

Jerome GJ, Young D, Laferriere D, Chen C, Vollmer WM. Reliability of RT3 Accelerometers Among Overweight and Obese Adults. Medicine and Science in Sports and Exercise; 2009 Jan;41(1):110-4.

Brantley, P.J., Appel, L.J., Hollis, J.F., Stevens, V.J., Ard, J.D., Champagne, C M.,  Elmer, P.J., Harsha, D.W., Myers, V.H., Proschan, M.A., Vollmer, W.M., & Svetkey, L.P.   Design considerations and rationale of a multi-center trial to sustain weight loss: The Weight Loss Maintenance Trial. Journal of the Society of Clinical Trials, 5 (5), 546-556. PMID: 18827047

Hollis JF, Gullion CM, Stevens VJ, Brantley PJ, Appel LJ, Ard JD, Champagne CM, Dalcin A, Erlinger TP, Funk K, Laferriere D, Lin PH, Loria CM, Samuel-Hodge C, Vollmer WM, Svetkey LP. Weight Loss During the Intensive Intervention Phase of the Weight-Loss Maintenance Trial. American Journal of Preventive Medicine. 2008 Aug; 35(2): 118-26.

Svetkey LP, Stevens VJ, Brantley PJ, Appel LJ, Hollis JF, Loria CM, Vollmer WM, Gullion CM, Funk K, Smith P, Samuel-Hodge C, Myers V, Lien LF, Laferriere D, Kennedy B, Jerome GJ, Heinith F, Harsha D, Evans P, Erlinger T, Dalcin AT, Coughlin J, Charleston J, Champagne CM, Bauck A, Ard JD, Aicher K for the Weight Loss Maintenance Collaborative Research Group. Comparison of Strategies for Sustaining Weight Loss: The Weight Loss Maintenance Randomized Controlled Trial. Journal of the American Medical Association. 2008 March, 12;299(10):1139-1148.

Ard J, Kumanyika SK, Stevens VJ, Vollmer WM, Samuel-Hodge C, Kennedy BM, Gayles D, Appel LJ, Brantley PJ, Champagne C, Charleston JB, Svetkey LP. Effect of group racial composition on weight loss in African Americans. Obesity 2008 Feb; 16(2):306-310.

Stevens V, Funk K, Brantley PJ, Erlinger TP, Myers VH, Champagne C, Bauck A, Samuel-Hodge CD, Hollis JF. Design and implementation of an interactive website to support long-term behavior change. Journal of Medical Internet Research 2008, January, 25; 10(1):e1.

Haqq AM, Lien LF, Boan J, Arlotto M, Slentz CA, Muehlbauer MJ, Rochon J, Gallup D, McMahon RL, Bain JR, Stevens R, Millington D, Butler MD, Newgard CB, Svetkey LP. The Study of the Effects of Diet on Metabolism and Nutrition (STEDMAN) Weight Loss Project: Rationale and Design. Contemporary Clinical Trials 2005, December; 26:616-625.

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