Approaches for Improving Long-term Weight Loss

NCT03799289 | Completed Results

• 2 other identifiers: 2096-18R03DK115978-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine two approaches for improving long-term weight loss success. All participants will receive a 12-week, in-person standard behavioral weight loss program followed by either 12 weeks of yoga instruction or 12 weeks of cooking/dietary education instruction (determined via randomization procedures). Assessments of weight, physical activity, dietary behaviors, and psychosocial factors will occur at baseline, 3, and 6 months.

Conditions

Obesity

Keywords

Obesity; Weight loss; physical activity; yoga; exercise

Outcome Measures

Primary Outcomes (3)

• Program Satisfaction Ratings

  Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied)

  6 months

• Intervention Session Attendance

  Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100).

  6 months

• Feasibility of the Intervention (Retention)

  Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment

  6 months

Secondary Outcomes (8)

• Changes in Perceived Stress (Measured Via the Perceived Stress Scale)

  Change from 12 to 24 weeks

• Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale

  Change from 12 to 24 weeks

• Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale

  Change from 12 to 24 weeks

• Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale

  Change from 12 to 24 weeks

• Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale

  Change from 12 to 24 weeks

Study Arms (2)

Iyengar Yoga

EXPERIMENTAL

Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.

Behavioral: Behavioral weight loss followed by yoga instruction

Cooking/dietary education

ACTIVE COMPARATOR

Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.

Behavioral: Behavioral weight loss followed by cooking/dietary education instruction

Interventions

Behavioral weight loss followed by yoga instruction BEHAVIORAL

12-week standard behavioral weight loss program followed by a 12-week yoga intervention

Iyengar Yoga

Behavioral weight loss followed by cooking/dietary education instruction BEHAVIORAL

12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention

Cooking/dietary education

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 25-40 kg/m2
• Female

You may not qualify if:

• Presence of any condition that would limit one's ability to exercise or lose weight safely
• Recent weight loss
• Current or recent enrollment in a weight loss or mindfulness-based treatment program
• Women who are pregnant or planning on becoming pregnant
• History of a serious psychiatric disorder
• Recent cancer diagnosis (\<1 year)
• Does not own a smartphone

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Results Point of Contact

• Title: Jessica Unick, PD (Principal Investigator)
• Organization: The Miriam Hospital

junick@lifespan.org

401-793-8966

Study Officials

• Jessica Unick, PhD

  The Miriam Hospital's Weight Control & Diabetes Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: January 10, 2019
• Study Start: January 3, 2019
• Primary Completion: June 18, 2020
• Study Completion: December 29, 2020
• Last Updated: October 28, 2021
• Results First Posted: October 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)