- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02368002
BestFIT: a Personalized Weight Loss Program
December 2, 2021 updated by: HealthPartners Institute
Evaluating Options for Non-Responders: A SMART Approach to Enhancing Weight Loss
The purpose of this study is to learn how to personalize weight loss programs. In this research we will study:
- 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
- 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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
468
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Bloomington, Minnesota, United States, 55425
- HealthPartners Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral weight loss therapy
Emphasizes 1) identifying behaviors in need of change, 2) setting goals for change, 3) monitoring progress, 4) modifying environmental cues to facilitate change, and 5) modifying consequences to motivate change.
|
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.
|
Experimental: Portion-controlled meals
Fifty percent of participants who have not lost the expected amount of weight will be re-randomized to receive portion-controlled meals in addition to standard behavioral weight loss therapy.
|
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.
|
Experimental: Acceptance-based treatment
Fifty percent of participants who have not lost the expected amount of weight will be re-randomized to receive an enhanced version of behavioral weight loss therapy teaching acceptance-based behavioral skills.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Change
Time Frame: 6 months and 18 months after baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Change
Time Frame: 6 and 18 months after baseline
|
Mixed model-estimated weight change from baseline to 6 and 18 months (pooled) among all randomized participants.
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6 and 18 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy E Sherwood, PhD, University of Minnesota
- Principal Investigator: A. Lauren Crain, PhD, HealthPartners Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1038/sj.ijo.0802258.
- 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. doi: 10.1016/j.amepre.2007.01.022.
- 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.
- 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. doi: 10.1016/j.jpsychores.2005.06.060.
- 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.
- 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.
- 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. doi: 10.1016/j.brat.2007.04.004. Epub 2007 Apr 18.
- 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.
- Emery Tavernier RL, Mason SM, Levy RL, Seburg EM, Sherwood NE. Association of childhood abuse with behavioral weight-loss outcomes: Examining the mediating effect of binge eating severity. Obesity (Silver Spring). 2022 Jan;30(1):96-105. doi: 10.1002/oby.23320.
- Sherwood NE, Crain AL, Seburg EM, Butryn ML, Forman EM, Crane MM, Levy RL, Kunin-Batson AS, Jeffery RW. BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. Ann Behav Med. 2022 Mar 1;56(3):291-304. doi: 10.1093/abm/kaab061.
- Crane MM, Seburg EM, Levy RL, Jeffery RW, Sherwood NE. Using targeting to recruit men and women of color into a behavioral weight loss trial. Trials. 2020 Jun 16;21(1):537. doi: 10.1186/s13063-020-04500-1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
February 6, 2015
First Submitted That Met QC Criteria
February 19, 2015
First Posted (Estimate)
February 20, 2015
Study Record Updates
Last Update Posted (Actual)
December 3, 2021
Last Update Submitted That Met QC Criteria
December 2, 2021
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01CA188892-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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