BestFIT: a Personalized Weight Loss Program

Sponsor
HealthPartners Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02368002
Collaborator
Drexel University (Other), University of Michigan (Other), University of Minnesota (Other), University of Washington (Other), National Cancer Institute (NCI) (NIH)
468
Enrollment
1
Location
3
Arms
49
Actual Duration (Months)
9.5
Patients Per Site Per Month

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:

  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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Behavioral weight loss therapy
  • Behavioral: Portion-controlled meals
  • Behavioral: Acceptance-based treatment
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:

  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 Design

Study Type:
Interventional
Actual Enrollment :
468 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating Options for Non-Responders: A SMART Approach to Enhancing Weight Loss
Actual Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

ArmIntervention/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

  1. 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

  1. 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

Ages Eligible for Study:
21 Years to 70 Years
Sexes Eligible for Study:
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:
  • 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

SiteCityStateCountryPostal Code
1HealthPartners InstituteBloomingtonMinnesotaUnited States55425

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

Responsible Party:
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT02368002
Other Study ID Numbers:
  • 1R01CA188892-01
  • 1R01CA188892-01
First Posted:
Feb 20, 2015
Last Update Posted:
Dec 3, 2021
Last Verified:
Jul 1, 2019
Keywords provided by HealthPartners Institute
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail26 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 TitleSession 3 Treatment Response AssessmentSession 3 Treatment Response Assessment & ABTSession 3 Treatment Response Assessment & PCMSession 7 Treatment Response AssessmentSession 7 Treatment Response Assessment & ABTSession 7 Treatment Response Assessment & PCM
Arm/Group DescriptionParticipants 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)
STARTED2330023500
COMPLETED2280021400
NOT COMPLETED5002100
Period Title: Stage 1 Intervention (Up to 20 Weeks)
STARTED887070000
COMPLETED866064000
NOT COMPLETED2106000
Period Title: Stage 1 Intervention (Up to 20 Weeks)
STARTED000955762
COMPLETED000945359
NOT COMPLETED000143

Baseline Characteristics

Arm/Group TitleWeek 3 Treatment Response AssessmentWeek 7 Treatment Response AssessmentPortion Controlled MealsAcceptance-based TreatmentTotal
Arm/Group DescriptionParticipants 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 Participants233235132127727
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

1. Primary Outcome
TitleWeight Change
DescriptionWeight change from baseline to 6 months and to 18 months among suboptimal responders to behavioral weight loss therapy.
Time Frame6 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 TitlePortion-controlled MealsAcceptance-based Treatment
Arm/Group DescriptionPortion-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 Participants132127
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 Hypothesisp-Value0.25
Comments2 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
MethodMixed Models Analysis
CommentsThe mixed model included a random participant intercept. Fixed covariates were baseline weight, TRA timing, sex, weight loss rate.
Other Statistical AnalysisThe 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
2. Secondary Outcome
TitleWeight Change
DescriptionMixed model-estimated weight change from baseline to 6 and 18 months (pooled) among all randomized participants.
Time Frame6 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 Title3 Week Treatment Response Assessment (Early TRA)7 Week Treatment Response Assessment (Late TRA)
Arm/Group DescriptionParticipants 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 Participants233235
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 Hypothesisp-Value0.96
Comments
MethodMixed Models Analysis
CommentsThe mixed model included a random participant intercept. Fixed covariates were baseline weight, sex, TRA result (PCM, ABT, responder, pre-TRA quit).
Method of EstimationEstimation ParameterMean 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 Frame6 months
Adverse Event Reporting Description
Arm/Group TitleWeek 3 Treatment Response AssessmentWeek 7 Treatment Response AssessmentPortion Controlled MealsAcceptance-based Treatment
Arm/Group DescriptionParticipants 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 AssessmentWeek 7 Treatment Response AssessmentPortion Controlled MealsAcceptance-based Treatment
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/233 (0%) 0/235 (0%) 0/132 (0%) 0/127 (0%)
Serious Adverse Events
Week 3 Treatment Response AssessmentWeek 7 Treatment Response AssessmentPortion Controlled MealsAcceptance-based Treatment
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/233 (0%) 3/235 (1.3%) 1/132 (0.8%) 2/127 (1.6%)
General disorders
Dehydration & Hypertension0/233 (0%) 01/235 (0.4%) 10/132 (0%) 00/127 (0%) 0
Psychiatric disorders
Depressive disorders0/233 (0%) 01/235 (0.4%) 10/132 (0%) 00/127 (0%) 0
Renal and urinary disorders
Kidney infection0/233 (0%) 00/235 (0%) 00/132 (0%) 01/127 (0.8%) 1
Reproductive system and breast disorders
Ovarian cancer0/233 (0%) 00/235 (0%) 01/132 (0.8%) 11/127 (0.8%) 1
Vascular disorders
Hypertension0/233 (0%) 01/235 (0.4%) 10/132 (0%) 00/127 (0%) 0
Other (Not Including Serious) Adverse Events
Week 3 Treatment Response AssessmentWeek 7 Treatment Response AssessmentPortion Controlled MealsAcceptance-based Treatment
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/233 (0%) 0/235 (0%) 0/132 (0%) 0/127 (0%)

Limitations/Caveats

[Not Specified]

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/TitleNancy Sherwood
OrganizationUniversity of Minnesota
Phone612-625-4567
Emailsherw005@umn.edu
Responsible Party:
HealthPartners Institute
ClinicalTrials.gov Identifier:
NCT02368002
Other Study ID Numbers:
  • 1R01CA188892-01
  • 1R01CA188892-01
First Posted:
Feb 20, 2015
Last Update Posted:
Dec 3, 2021
Last Verified:
Jul 1, 2019