Self-compassion and Nutrition (SCAN) Study

August 30, 2021 updated by: Jessica Unick, The Miriam Hospital

Comparison of Two Approaches for Improving Long-term Weight Loss Among Individuals With Severe Obesity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • The Miriam Hospital's Weight Control and Diabetes Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment feasibility will be assessed by the number of participants screened and enrolled
Time Frame: 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
At the end of the study, up to 9 months post-baseline
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
6 months
Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit
Time Frame: 9 months
Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent weight change at 6 months
Time Frame: 6 months after study enrollment
6 months after study enrollment
Percent weight change at 9 months
Time Frame: 9 months after study enrollment
9 months after study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

April 9, 2021

Study Completion (Actual)

July 13, 2021

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1569066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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