BestFIT: a Personalized Weight Loss Program

Obesity Clinical Trial

Official title:

Evaluating Options for Non-Responders: A SMART Approach to Enhancing Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368002
• Other study ID #: 1R01CA188892-01
• Secondary ID: 1R01CA188892-01
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: June 2019

Study information

• Verified date: July 2019
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn how to personalize weight loss programs. In this research we will study: 1. Whether a weight loss counselor should decide if the traditional weight loss therapy is working either after 3 or 7 weekly sessions of therapy and 2. For those who haven't lost the expected amount of weight, whether it is more effective to add packaged meals to the traditional weight loss therapy or to change to an enhanced version of behavioral weight loss therapy.

Description:

The US Preventive Services Task Force recommends referral to behavioral weight loss programs to help obese adults achieve a clinically meaningful weight loss of 8-10% of starting body weight. However, approximately half of participants are unable to achieve this goal. Despite this, a"one size fits all" approach is the norm, a major drawback because those who do not respond can in fact be detected early. This gap in weight loss intervention science calls for an adaptive intervention approach that could provide the "right treatment at the right time for the right person". Adaptive interventions individualize treatment through empirically-supported decision rules advising when and how treatments should unfold over time to maximize effectiveness. Sequential Multiple Assignment Randomized Trials (SMART), developed explicitly to build the best adaptive interventions, use experimental design principles to develop these decision rules. The investigators will use a SMART to systematically evaluate therapeutic approach and timing differences for intervening with those who do not respond to a behavioral weight loss program. Self-regulation challenges have been identified as a major adherence barrier. Two attractive options to address self-regulation difficulties are: 1) supplementing behavioral treatment with Meal Replacements (MR) which decreases the need for self-regulation; and 2) switching therapeutic approaches by using an enhanced version of behavioral weight loss therapy that teaches acceptance based behavioral skills which boost capacity for self-regulation. Additionally, two time points for intervening with non-responders will be evaluated: 1) 3 weeks, based on current weight loss trial evidence; and 2) 7 weeks, based on average time used in the existing stepped care literature. Adults (n=500) will be recruited and will receive individual behavioral weight loss treatment (BWL). Participants will be randomized to either: 1) treatment response assessment at 3 weeks or 2) treatment response assessment at 7 weeks. Subjects who have lost the expected amount of weight at their assessment point, will continue with traditional behavioral weight loss therapy. For those who have not lost the expected amount of weight, we will re-randomize them to either meal replacements in addition to the traditional weight loss therapy or to the enhanced version of behavioral weight loss therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: June 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Between the ages of 21 - 70
• BMI between 30 - 45 kg/m2
• Able to walk 2 blocks without stopping
• Able to attend measurement and intervention activities in the Twin Cities area in person for 18 months

Exclusion Criteria:

• Self-reported pregnancy or breastfeeding baby in last 6 months or planning a pregnancy in the next 18 months
• History of bariatric surgery
• Current or previous diagnosis of anorexia nervosa or bulimia nervosa
• Food allergies, intolerances

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Behavioral weight loss therapy
All participants start with behavioral weight loss therapy which consists of 20 weekly meetings wtih a weight loss coach. Session components will include weekly weigh-in, discussion of progress and challenges and discussion of scheduled session topic. Dietary goals and physical activity goals are set. After their first session, participants are randomized to have their weight assessed at either their 3rd session or their 7th session. Both the participant and their coach are blinded to the randomization. If the participant has lost the expected amount of weight, they continue with behavioral weight loss therapy for the full 20 session.
• Portion-controlled meals
Participants continue with behavioral weight loss therapy, but this is augmented with portion-controlled meals (PCM). Adherence to energy intake goals is facilitated by consuming pre-prepared meals specifically designed to meet caloric intake guidelines. PCMs reduce individuals' motivationally- and self-regulatory-dependent planning and decision making around eating. PCMs also serve as a "teaching tool" regarding the amount and type of food people should eat in order to produce weight loss.
• Acceptance-based treatment
Switching the therapeutic approach to an enhanced behavioral weight loss therapy teaching acceptance-based behavioral skills theoretically addresses the root problem of many weight loss challenges and boosts long-term capacity for self-regulation. Acceptance based strategies are designed to help participants identify and internalize values and lasting commitment to behavior consistent with these values. The strategies focus on increasing people's ability to forgo more pleasurable options (e.g., hedonic pleasure of food) in favor of behavior that is distinctly less pleasurable or even aversive (remaining hungry, anxious, bored). The inability to tolerate such distress is directly associated with failure of self-regulation.

Locations

Country	Name	City	State
United States	HealthPartners Institute	Bloomington	Minnesota

Sponsors (6)

Lead Sponsor	Collaborator
HealthPartners Institute	Drexel University, National Cancer Institute (NCI), University of Michigan, University of Minnesota, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (8)

Butryn ML, Webb V, Wadden TA. Behavioral treatment of obesity. Psychiatr Clin North Am. 2011 Dec;34(4):841-59. doi: 10.1016/j.psc.2011.08.006. Review. — View Citation

Carels RA, Darby L, Cacciapaglia HM, Douglass OM, Harper J, Kaplar ME, Konrad K, Rydin S, Tonkin K. Applying a stepped-care approach to the treatment of obesity. J Psychosom Res. 2005 Dec;59(6):375-83. — View Citation

Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. — View Citation

Forman EM, Hoffman KL, McGrath KB, Herbert JD, Brandsma LL, Lowe MR. A comparison of acceptance- and control-based strategies for coping with food cravings: an analog study. Behav Res Ther. 2007 Oct;45(10):2372-86. Epub 2007 Apr 18. — View Citation

Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. — View Citation

Lei H, Nahum-Shani I, Lynch K, Oslin D, Murphy SA. A "SMART" design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012;8:21-48. doi: 10.1146/annurev-clinpsy-032511-143152. Epub 2011 Dec 12. Review. — View Citation

Rock CL, Flatt SW, Sherwood NE, Karanja N, Pakiz B, Thomson CA. Effect of a free prepared meal and incentivized weight loss program on weight loss and weight loss maintenance in obese and overweight women: a randomized controlled trial. JAMA. 2010 Oct 27;304(16):1803-10. doi: 10.1001/jama.2010.1503. Epub 2010 Oct 9. — View Citation

Sherwood NE, Butryn ML, Forman EM, Almirall D, Seburg EM, Lauren Crain A, Kunin-Batson AS, Hayes MG, Levy RL, Jeffery RW. The BestFIT trial: A SMART approach to developing individualized weight loss treatments. Contemp Clin Trials. 2016 Mar;47:209-16. doi: 10.1016/j.cct.2016.01.011. Epub 2016 Jan 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Change	Weight change from baseline to 6 months and to 18 months among suboptimal responders to behavioral weight loss therapy.	6 months and 18 months after baseline
Secondary	Weight Change	Mixed model-estimated weight change from baseline to 6 and 18 months (pooled) among all randomized participants.	6 and 18 months after baseline