BestFIT: a Personalized Weight Loss Program
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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:
- 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 Design
Arms and Interventions
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. |
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.
|
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
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. |
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Weight Change [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.
Secondary Outcome Measures
- Weight Change [6 and 18 months after baseline]
Mixed model-estimated weight change from baseline to 6 and 18 months (pooled) among all randomized participants.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | HealthPartners Institute | Bloomington | Minnesota | United States | 55425 |
Sponsors and Collaborators
- HealthPartners Institute
- Drexel University
- University of Michigan
- University of Minnesota
- University of Washington
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Nancy E Sherwood, PhD, University of Minnesota
- Principal Investigator: A. Lauren Crain, PhD, HealthPartners Institute
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 1R01CA188892-01
- 1R01CA188892-01
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 26 participants were lost to follow-up or quit after the initial randomization to the 3 or 7 week treatment response assessment and prior to the treatment response assessment. These participants are included in the session 3 and session 7 treatment response assessment & no-randomization groups. |
Arm/Group Title | Session 3 Treatment Response Assessment | Session 3 Treatment Response Assessment & ABT | Session 3 Treatment Response Assessment & PCM | Session 7 Treatment Response Assessment | Session 7 Treatment Response Assessment & ABT | Session 7 Treatment Response Assessment & PCM |
---|---|---|---|---|---|---|
Arm/Group Description | Participants randomized to treatment response assessment at session 3. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 3. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs. | Participants randomized to treatment response assessment at session 3 and re-randomized to acceptance-based treatment (ABT). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 3 treatment response assessment and were re-randomized to switch to ABT. | Participants randomized to treatment response assessment at session 3 and re-randomized to portion controlled meals (PCM). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 3 treatment response assessment and were re-randomized to behavioral weight loss therapy augmented with PCM. | Participants randomized to treatment response assessment at session 7. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 7. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs. | Participants randomized to treatment response assessment at session 7 and re-randomized to acceptance-based treatment (ABT). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 7 treatment response assessment and were re-randomized to switch to ABT. | Participants randomized to treatment response assessment at session 7 and re-randomized to portion controlled meals (PCM). Participants started with standard behavioral weight loss treatment. Participants did not lose the expected amount of weight at the session 7 treatment response assessment and were re-randomized to behavioral weight loss therapy augmented with PCM. |
Period Title: Stage 1 Intervention (Up to 20 Weeks) | ||||||
STARTED | 233 | 0 | 0 | 235 | 0 | 0 |
COMPLETED | 228 | 0 | 0 | 214 | 0 | 0 |
NOT COMPLETED | 5 | 0 | 0 | 21 | 0 | 0 |
Period Title: Stage 1 Intervention (Up to 20 Weeks) | ||||||
STARTED | 88 | 70 | 70 | 0 | 0 | 0 |
COMPLETED | 86 | 60 | 64 | 0 | 0 | 0 |
NOT COMPLETED | 2 | 10 | 6 | 0 | 0 | 0 |
Period Title: Stage 1 Intervention (Up to 20 Weeks) | ||||||
STARTED | 0 | 0 | 0 | 95 | 57 | 62 |
COMPLETED | 0 | 0 | 0 | 94 | 53 | 59 |
NOT COMPLETED | 0 | 0 | 0 | 1 | 4 | 3 |
Baseline Characteristics
Arm/Group Title | Week 3 Treatment Response Assessment | Week 7 Treatment Response Assessment | Portion Controlled Meals | Acceptance-based Treatment | Total |
---|---|---|---|---|---|
Arm/Group Description | Participants randomized to have their weight assessed at their 3rd session. If the participant has lost the expected amount of weight, they continue with standard behavioral weight loss treatment for the full 20 sessions. If they have not lost the expected amount of weight, they are re-randomized to portion controlled meals or acceptance-based treatment. | Participants randomized to have their weight assessed at their 7th session. If the participant has lost the expected amount of weight, they continue with standard behavioral weight loss treatment for the full 20 sessions. If they have not lost the expected amount of weight, they are re-randomized to portion controlled meals or acceptance-based treatment. | Portion controlled meals: Participants assessed at the 3rd or 7th session who did not lose the expected amount of weight and were re-randomized to continue with behavioral weight loss therapy that is augmented with portion controlled meals (PCM). | Acceptance-based treatment: Participants assessed at the 3rd or 7th session who did not lose the expected amount of weight and were re-randomized to switching the therapeutic approach to an acceptance-based treatment. | Total of all reporting groups |
Overall Participants | 233 | 235 | 132 | 127 | 727 |
Age (Count of Participants) | |||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
||
Between 18 and 65 years |
224
96.1%
|
225
95.7%
|
449
340.2%
|
||
>=65 years |
9
3.9%
|
10
4.3%
|
19
14.4%
|
||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
||
Between 18 and 65 years |
125
53.6%
|
125
53.2%
|
250
189.4%
|
||
>=65 years |
7
3%
|
2
0.9%
|
9
6.8%
|
||
Sex: Female, Male (Count of Participants) | |||||
Female |
179
76.8%
|
178
75.7%
|
357
270.5%
|
||
Male |
54
23.2%
|
57
24.3%
|
111
84.1%
|
||
Female |
111
47.6%
|
111
47.2%
|
222
168.2%
|
||
Male |
21
9%
|
16
6.8%
|
37
28%
|
||
Race/Ethnicity, Customized (Count of Participants) | |||||
Non-Hispanic White |
177
76%
|
189
80.4%
|
366
277.3%
|
||
Non-Hispanic Black |
34
14.6%
|
20
8.5%
|
54
40.9%
|
||
Hispanic, Any Race |
9
3.9%
|
15
6.4%
|
24
18.2%
|
||
Other |
13
5.6%
|
11
4.7%
|
24
18.2%
|
||
Non-Hispanic White |
103
44.2%
|
96
40.9%
|
199
150.8%
|
||
Non-Hispanic Black |
18
7.7%
|
15
6.4%
|
33
25%
|
||
Hispanic, Any Race |
4
1.7%
|
8
3.4%
|
12
9.1%
|
||
Other |
7
3%
|
8
3.4%
|
15
11.4%
|
||
Weight (pounds) [Mean (Standard Deviation) ] | |||||
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)
|
Outcome Measures
Title | Weight Change |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants included in this analysis were suboptimal responders to behavioral weight loss therapy whose initial treatment was augmented with portion-controlled meals or switched to acceptance-based treatment. |
Arm/Group Title | Portion-controlled Meals | Acceptance-based Treatment |
---|---|---|
Arm/Group Description | Portion-controlled meals: Participants continue with behavioral weight loss therapy, but this is augmented with portion-controlled meals (PCM). | Acceptance-based treatment: Participants switch to treatment teaching acceptance-based behavioral skills. |
Measure Participants | 132 | 127 |
6M |
-18.4
|
-15.7
|
18M |
-8.5
|
-7.4
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Portion-controlled Meals, Acceptance-based Treatment |
---|---|---|
Comments | H1 predicted that suboptimal responders re-randomized to PCM would lose more weight at 6m (H1a) while those re-randomized to ABT would lose more weight at 18m (H1b). A mixed linear model predicted weight change from fixed re-randomization, measurement time, the re-randomization by measurement time interaction and covariate parameters. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.25 |
Comments | 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 | |
Method | Mixed Models Analysis | |
Comments | The mixed model included a random participant intercept. Fixed covariates were baseline weight, TRA timing, sex, weight loss rate. | |
Other Statistical Analysis | The primary hypothesis tests were two planned contrasts that estimated weight change from baseline to 6M and 18M relative to baseline in PCM relative to ABT. A mixed linear model predicted weight changes between baseline and post-baseline for suboptimal responders, and this model included two a priori simple effects tests resulting in two mean differences, confidence intervals, and p-values. H1a: -2.7 lbs; 95% CI: -5.8, 0.5; p=0.09. H1b: -1.0 lbs; 95% CI: -4.2, 2.2; p=0.53 |
Title | Weight Change |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants included in this analysis were all randomized participants, who had been randomly assigned to be assessed for treatment response 3 weeks (Early TRA) or 7 weeks (Late TRA) after initiating behavioral weight loss therapy. |
Arm/Group Title | 3 Week Treatment Response Assessment (Early TRA) | 7 Week Treatment Response Assessment (Late TRA) |
---|---|---|
Arm/Group Description | Participants all began by receiving Standard Behavioral Weight Loss Treatment (SBT) sessions. Participants were randomized to treatment response assessment (TRA) at Week 3. | Participants all began by receiving Standard Behavioral Weight Loss Treatment (SBT) sessions. Participants were randomized to treatment response assessment (TRA) at Week 7. |
Measure Participants | 233 | 235 |
Mean (95% Confidence Interval) [pounds] |
-16.6
|
-16.7
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Portion-controlled Meals, Acceptance-based Treatment |
---|---|---|
Comments | Hypothesis 2 predicted that among all participants, those randomized to Early TRA would lose more weight at 6 and 18 months than those randomized to Late TRA. A mixed linear model predicted weight change from fixed treatment response assessment timing and covariate parameters. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.96 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | The mixed model included a random participant intercept. Fixed covariates were baseline weight, sex, TRA result (PCM, ABT, responder, pre-TRA quit). | |
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -2.4 to 2.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | 6 months | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | Week 3 Treatment Response Assessment | Week 7 Treatment Response Assessment | Portion Controlled Meals | Acceptance-based Treatment | ||||
Arm/Group Description | Participants randomized to treatment response assessment at session 3. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 3. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs. | Participants randomized to treatment response assessment at session 7. All participants start with standard behavioral weight loss treatment, and treatment response assessment occurs at session 7. If participants lost the expected amount of weight, no re-randomization occurs and participants continue with standard behavioral weight loss treatment. If participants did not lose the expected amount of weight, re-randomization to PCM or ABT occurs. | Portion controlled meals: Participants did not lose enough weight at the treatment response assessment (occurs at session 3 or session 7) and were re-randomized to portion controlled meals. | Acceptance-based treatment: Participants did not lose enough weight at the treatment response assessment (occurs at session 3 or session 7) and were re-randomized to acceptance-based treatment. | ||||
All Cause Mortality |
||||||||
Week 3 Treatment Response Assessment | Week 7 Treatment Response Assessment | Portion Controlled Meals | Acceptance-based Treatment | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/233 (0%) | 0/235 (0%) | 0/132 (0%) | 0/127 (0%) | ||||
Serious Adverse Events |
||||||||
Week 3 Treatment Response Assessment | Week 7 Treatment Response Assessment | Portion Controlled Meals | Acceptance-based Treatment | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/233 (0%) | 3/235 (1.3%) | 1/132 (0.8%) | 2/127 (1.6%) | ||||
General disorders | ||||||||
Dehydration & Hypertension | 0/233 (0%) | 0 | 1/235 (0.4%) | 1 | 0/132 (0%) | 0 | 0/127 (0%) | 0 |
Psychiatric disorders | ||||||||
Depressive disorders | 0/233 (0%) | 0 | 1/235 (0.4%) | 1 | 0/132 (0%) | 0 | 0/127 (0%) | 0 |
Renal and urinary disorders | ||||||||
Kidney infection | 0/233 (0%) | 0 | 0/235 (0%) | 0 | 0/132 (0%) | 0 | 1/127 (0.8%) | 1 |
Reproductive system and breast disorders | ||||||||
Ovarian cancer | 0/233 (0%) | 0 | 0/235 (0%) | 0 | 1/132 (0.8%) | 1 | 1/127 (0.8%) | 1 |
Vascular disorders | ||||||||
Hypertension | 0/233 (0%) | 0 | 1/235 (0.4%) | 1 | 0/132 (0%) | 0 | 0/127 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
Week 3 Treatment Response Assessment | Week 7 Treatment Response Assessment | Portion Controlled Meals | Acceptance-based Treatment | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/233 (0%) | 0/235 (0%) | 0/132 (0%) | 0/127 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Nancy Sherwood |
---|---|
Organization | University of Minnesota |
Phone | 612-625-4567 |
sherw005@umn.edu |
- 1R01CA188892-01
- 1R01CA188892-01