Self-compassion and Nutrition (SCAN) Study

Sponsor
The Miriam Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04289636
Collaborator
(none)
28
1
2
10.3
2.7

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the feasibility of two approaches for improving long-term weight loss success among individuals with severe obesity. All participants will receive a 15-week, standard behavioral weight loss program followed by either 8 weeks of a mindfulness self-compassion intervention or 8 weeks of a nutrition and cooking education intervention (determined via randomization procedures). Assessments of weight, physical activity, and other weight-related and psychosocial factors will occur at baseline, 4 months, 6 months, and 9 months.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral weight loss program
  • Behavioral: Self-compassion
  • Behavioral: Nutrition and cooking education
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Two Approaches for Improving Long-term Weight Loss Among Individuals With Severe Obesity
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Apr 9, 2021
Actual Study Completion Date :
Jul 13, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Weight loss and self-compassion

Participants will receive a 15-week behavioral weight loss program which teaches strategies for changing diet and exercise behaviors. This will consist of a combination of group and individual sessions. Group classes will be delivered remotely via a video-conferencing platform. This will be followed by an 8-week mindfulness-based self-compassion program which combines the skills of mindfulness and self-compassion as a means for improving emotional resilience, well-being, and weight control.

Behavioral: Behavioral weight loss program
Using a combination of individual (~1x/month) and group-based (~3x/month) meetings, participants will be taught behavioral approaches for changing diet and exercise behaviors. This intervention will be 15 weeks in duration and will be delivered remotely using a video-conferencing platform.

Behavioral: Self-compassion
This 8-week, group-based program will help train individuals on how to handle difficult emotions with greater ease, how to transform difficult relationships, and how to motivate and encourage oneself, rather than being self-critical.

Active Comparator: Weight loss and nutrition/cooking education

Participants will receive a 15-week behavioral weight loss program which teaches strategies for changing diet and exercise behaviors. This will consist of a combination of group and individual sessions. Group classes will be delivered remotely via a video-conferencing platform. This will be followed by an 8-week nutrition and cooking education program which will provide basic nutrition knowledge and cooking skills for healthy eating.

Behavioral: Behavioral weight loss program
Using a combination of individual (~1x/month) and group-based (~3x/month) meetings, participants will be taught behavioral approaches for changing diet and exercise behaviors. This intervention will be 15 weeks in duration and will be delivered remotely using a video-conferencing platform.

Behavioral: Nutrition and cooking education
This 8-week, group-based program will help individuals to improve the quality of their diet through nutrition education and basic cooking skills for preparing healthy meals.

Outcome Measures

Primary Outcome Measures

  1. Recruitment feasibility will be assessed by the number of participants screened and enrolled [At the end of the study, up to 9 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). [6 months]

    The feasibility of the intervention will be assessed by calculating the overall session attendance

  3. Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit [9 months]

    Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit

Secondary Outcome Measures

  1. Percent weight change at 6 months [6 months after study enrollment]

  2. Percent weight change at 9 months [9 months after study enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age 18-65 years

  • BMI between 40 - 55 kg/m2

  • Female

  • Score high on internalized weight bias

Exclusion Criteria:
  • Presence of any condition that would limit one's ability to exercise (i.e., orthopedic limitations)

  • Recent weight loss (≥15 pounds within the past 6 months)

  • History of bariatric surgery

  • Current or recent enrollment (completed <1 year ago) in a weight loss program at the Weight Control and Diabetes Research Center

  • Currently taking any weight loss or other medication that could alter one's metabolism

  • Women who are pregnant, planning on becoming pregnant in the next 6 months, or those pregnant within the past 6 months

  • Serious psychiatric disorder (e.g., psychosis, major depression, suicidality) -

  • Participants with a history of diabetes or heart disease will be considered for this study only if their heart disease or diabetes is well controlled, and physician consent will be required.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Miriam Hospital's Weight Control and Diabetes Research Center Providence Rhode Island United States 02903

Sponsors and Collaborators

  • The Miriam Hospital

Investigators

  • Principal Investigator: Jessica L Unick, PhD, The Miriam Hospital's Weight Control & Diabetes Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jessica Unick, Assistant Professor (Research), The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT04289636
Other Study ID Numbers:
  • 1569066
First Posted:
Feb 28, 2020
Last Update Posted:
Aug 31, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jessica Unick, Assistant Professor (Research), The Miriam Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 31, 2021