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Approaches for Improving Long-term Weight Loss

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ClinicalTrials.gov Identifier: NCT03799289
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The Miriam Hospital

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, 6, and 12 months.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Behavioral weight loss followed by yoga instruction Behavioral: Behavioral weight loss followed by cooking/dietary education instruction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examination of the Feasibility and Preliminary Efficacy of Two Approaches for Improving Long-term Weight Loss
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yoga
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
12-week standard behavioral weight loss program followed by a 12-week yoga intervention

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




Primary Outcome Measures :
  1. Recruitment feasibility will be assessed by the number of participants screened and enrolled [ Time Frame: At the end of the study, up to 6 months post-baseline ]
    Recruitment feasibility will be assessed by the number of participants screened and enrolled

  2. Session attendance will be assessed by calculating the overall session attendance (# of sessions completed/# of sessions possible). [ Time Frame: 6 months ]
    The feasibility of the intervention will be assessed by calculating the overall session attendance (# of sessions completed/# of sessions possible).

  3. Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 6-month assessment visit. [ Time Frame: 6 months ]
    The acceptability of the interventions will be determined by the percentage of participants completing the 6-month assessment visit.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 25-40 kg/m2
  • Female

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799289


Contacts
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Contact: Tiffany Leblond 401-793-9713 tleblond@lifespan.org

Locations
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United States, Rhode Island
Weight Control and Diabetes Research Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Tiffany Leblond         
Principal Investigator: Jessica Unick, PhD         
Sponsors and Collaborators
The Miriam Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Jessica Unick, PhD The Miriam Hospital's Weight Control & Diabetes Research Center
  Study Documents (Full-Text)

Documents provided by The Miriam Hospital:
Informed Consent Form  [PDF] May 3, 2019


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Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT03799289     History of Changes
Other Study ID Numbers: 2096-18
R03DK115978-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Miriam Hospital:
Obesity
Weight loss
physical activity
yoga
exercise
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes