CompletedNCT02368002Updated Dec 3, 2021Results posted

BestFIT: a Personalized Weight Loss Program

An interventional study of Behavioral weight loss therapy and Portion-controlled meals in Obesity, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-03.

Sponsored by HealthPartners Institute · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 468
Allocation: Randomized
Ages: 21 Years to 70 Years
Sex: All

Study summary

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.

Read the 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.

Conditions studied

Obesity

Browse trials for

Weight Loss 1,766

Keywords

obesity
diet, reducing

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 468 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 468 participants (actual)

Study arms

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.
Behavioral: Behavioral weight loss therapy
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.
Behavioral: Portion-controlled meals
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.
Behavioral: Acceptance-based treatment

Interventions

BehavioralBehavioral 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.
BehavioralPortion-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.
BehavioralAcceptance-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.

What researchers measure

Primary outcomes

Weight Change
Weight change from baseline to 6 months and to 18 months among suboptimal responders to behavioral weight loss therapy.
Time frame: 6 months and 18 months after baseline

Secondary outcomes

Weight Change
Mixed model-estimated weight change from baseline to 6 and 18 months (pooled) among all randomized participants.
Time frame: 6 and 18 months after baseline

Results

Posted Dec 3, 2021

Participant flow

Stage 1 Intervention (Up to 20 Weeks)

Participant flow — Stage 1 Intervention (Up to 20 Weeks)
Milestone	Session 3 Treatment Response Assessment	Session 7 Treatment Response Assessment
Started	233	235
Completed	228	214
Not completed	5	21

Stage 2 Intervention (Up to 17 Weeks)

Participant flow — Stage 2 Intervention (Up to 17 Weeks)
Milestone	Session 3 Treatment Response Assessment	Session 3 Treatment Response Assessment & ABT	Session 3 Treatment Response Assessment & PCM
Started	88	70	70
Completed	86	60	64
Not completed	2	10	6

Stage 2 Intervention (Up to 13 Weeks)

Participant flow — Stage 2 Intervention (Up to 13 Weeks)
Milestone	Session 7 Treatment Response Assessment	Session 7 Treatment Response Assessment & ABT	Session 7 Treatment Response Assessment & PCM
Started	95	57	62
Completed	94	53	59
Not completed	1	4	3

Outcome measures

PrimaryWeight Change

Weight change from baseline to 6 months and to 18 months among suboptimal responders to behavioral weight loss therapy.

Time frame:: 6 months and 18 months after baseline
Reported as:: Mean · pounds

Weight Change
pounds	Portion-controlled Meals	Acceptance-based Treatment
6M	-18.4 (-20.5 to -16.2)	-15.7 (-18.0 to -13.4)
18M	-8.5 (-10.7 to -6.3)	-7.4 (-9.7 to -5.2)

Statistical analysis

Portion-controlled Meals vs Acceptance-based Treatment · Mixed Models Analysis · p = 0.25 (2 df re-random\*time interaction tested if baseline to 6M or 18M PCM and ABT weight changes differed; primary hypothesis tests were 2 planned contrasts estimating baseline to 6M (H1a, expected neg) and 18M (H1b, expected pos) PCM vs. ABT weight change)The mixed model included a random participant intercept. Fixed covariates were baseline weight, TRA timing, sex, weight loss rate.

SecondaryWeight Change

Mixed model-estimated weight change from baseline to 6 and 18 months (pooled) among all randomized participants.

Time frame:: 6 and 18 months after baseline
Reported as:: Mean · pounds

Weight Change
pounds	3 Week Treatment Response Assessment (Early TRA)	7 Week Treatment Response Assessment (Late TRA)
Weight Change	-16.6 (-18.3 to -14.9)	-16.7 (-18.4 to -15.0)

Statistical analysis

3 Week Treatment Response Assessment (Early TRA) vs 7 Week Treatment Response Assessment (Late TRA) · Mixed Models Analysis · p = 0.96 · Mean difference (net): -0.1 · 95% CI -2.4 to 2.3The mixed model included a random participant intercept. Fixed covariates were baseline weight, sex, TRA result (PCM, ABT, responder, pre-TRA quit).

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Week 3 Treatment Response Assessment	0/233 (0%)	0/233 (0%)	0/233 (0%)
Week 7 Treatment Response Assessment	0/235 (0%)	3/235 (1.3%)	0/235 (0%)
Portion Controlled Meals	0/132 (0%)	1/132 (0.8%)	0/132 (0%)
Acceptance-based Treatment	0/127 (0%)	2/127 (1.6%)	0/127 (0%)

Most frequent serious events

Most frequent serious events
Event	Week 3 Treatment Response Assessment	Week 7 Treatment Response Assessment	Portion Controlled Meals	Acceptance-based Treatment
Kidney infectionRenal and urinary disorders	0/233	0/235	0/132	1/127
Ovarian cancerReproductive system and breast disorders	0/233	0/235	1/132	1/127
Depressive disordersPsychiatric disorders	0/233	1/235	0/132	0/127
HypertensionVascular disorders	0/233	1/235	0/132	0/127
Dehydration & HypertensionGeneral disorders	0/233	1/235	0/132	0/127

Baseline characteristics

Participants who were re-randomized to a second line treatment (PCM or ABT) are represented more than once in the Total Arm/Group. They are included in either the Week 3 or Week 7 treatment response assessment group and the Portion controlled meals or Acceptance-based treatment group.

Age, Categorical
Age, Categorical(Participants)	Week 3 Treatment Response Assessment	Week 7 Treatment Response Assessment	Portion Controlled Meals	Acceptance-based Treatment	Total
Stage 1 Randomization — <=18 years	0	0	—	—	0
Stage 1 Randomization — Between 18 and 65 years	224	225	—	—	449
Stage 1 Randomization — >=65 years	9	10	—	—	19
Stage 2 Re-Randomization — <=18 years	—	—	0	0	0
Stage 2 Re-Randomization — Between 18 and 65 years	—	—	125	125	250
Stage 2 Re-Randomization — >=65 years	—	—	7	2	9

Sex: Female, Male
Sex: Female, Male(Participants)	Week 3 Treatment Response Assessment	Week 7 Treatment Response Assessment	Portion Controlled Meals	Acceptance-based Treatment	Total
Stage 1 Randomization — Female	179	178	—	—	357
Stage 1 Randomization — Male	54	57	—	—	111
Stage 2 Re-Randomization — Female	—	—	111	111	222
Stage 2 Re-Randomization — Male	—	—	21	16	37

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Week 3 Treatment Response Assessment	Week 7 Treatment Response Assessment	Portion Controlled Meals	Acceptance-based Treatment	Total
Stage 1 Randomization — Non-Hispanic White	177	189	—	—	366
Stage 1 Randomization — Non-Hispanic Black	34	20	—	—	54
Stage 1 Randomization — Hispanic, Any Race	9	15	—	—	24
Stage 1 Randomization — Other	13	11	—	—	24
Stage 2 Re-Randomization — Non-Hispanic White	—	—	103	96	199
Stage 2 Re-Randomization — Non-Hispanic Black	—	—	18	15	33
Stage 2 Re-Randomization — Hispanic, Any Race	—	—	4	8	12
Stage 2 Re-Randomization — Other	—	—	7	8	15

Weight
Weight(pounds)	Week 3 Treatment Response Assessment	Week 7 Treatment Response Assessment	Portion Controlled Meals	Acceptance-based Treatment	Total
Stage 1 Randomization	225.1 ± 34.82	224.1 ± 34.25	—	—	224.6 ± 34.50
Stage 2 Re-Randomization	—	—	222.8 ± 34.55	222 ± 33.37	222.4 ± 33.91

Study locations

1 site

HealthPartners Institute
Bloomington, Minnesota 55425, United States

References and documents

Publications

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. PubMed 16310019 ↗
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. PubMed 22224838 ↗
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. PubMed 17466815 ↗
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. PubMed 22098808 ↗
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. PubMed 20935338 ↗
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. PubMed 12704397 ↗
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. PubMed 17544361 ↗
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. PubMed 26825020 ↗
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. PubMed 34932887 ↗
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. PubMed 34415011 ↗
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. PubMed 32546253 ↗

Study documents

Protocol and statistical analysis plan · Jun 12, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02368002
Lead sponsor: HealthPartners Institute
Collaborators: Drexel University, University of Michigan, University of Minnesota, University of Washington, National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Feb 20, 2015
Start date: May 2015
Primary completion: Apr 2019
Completion: Jun 2019
Results posted: Dec 3, 2021
Last update: Dec 3, 2021

Study contacts

Nancy E Sherwood, PhD

principal investigator · University of Minnesota

A. Lauren Crain, PhD

principal investigator · HealthPartners Institute

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Weight Loss→

Other studies from this sponsor

HealthPartners Institute

Start the discussion