N/A
N=468
BestFIT: a Personalized Weight Loss Program
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02368002 ↗Enrolled (actual)
468
Serious AEs
0.8%
Results posted
Dec 2021
Primary outcome: Primary: Weight Change — -18.4; -15.7; -8.5; -7.4 pounds — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral weight loss therapy (Behavioral); Portion-controlled meals (Behavioral); Acceptance-based treatment (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Change |
-16.6; -16.7 | 0.96 |
| SECONDARY Weight Change |
-16.6; -16.7 | 0.96 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02368002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.