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Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes

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Lifespan

Status

Completed

Conditions

Obesity

Treatments

Behavioral: SR
Behavioral: WLO
Behavioral: ACT

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02156752
5K23KDK097143

Details and patient eligibility

About

This project is a randomized controlled trial to compare the efficacy of two interventions- one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)- and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All participants will first participate in an initial 4-month standard behavioral weight loss program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop; the ACT workshop will teach ACT skills including acceptance and mindfulness techniques designed to promote behavior change and health behavior persistence consistent with one's core values. The SR program will focus on self-regulation, regular weighing, and modeling behavior on successful maintainers. The WLO group will receive a control workshop focused on cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24 months. The secondary outcome is change in psychological flexibility, a critical component of ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24 months, the ACT group will show significantly greater weight loss as compared to the SR and WLO groups.

Enrollment

190 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • BMI 27.5-40
  • Age 30-65

Exclusion criteria

  • currently participating in a weight loss program
  • pregnant or planning to become pregnant
  • medical condition that would preclude physical activity
  • terminal illness
  • plans to relocate
  • history of substance abuse or psychological problems that are judged by the investigators to be likely to interfere with study participation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

190 participants in 3 patient groups

ACT
Experimental group
Description:
Behavioral weight loss plus techniques from Acceptance and Commitment Therapy
Treatment:
Behavioral: ACT
SR
Active Comparator group
Description:
Behavioral weight loss plus self-regulation techniques
Treatment:
Behavioral: SR
WLO
Active Comparator group
Description:
Behavioral weight loss plus cooking tips and demonstrations
Treatment:
Behavioral: WLO

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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