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Self-compassion and Nutrition (SCAN) Study

Primary Purpose

Obesity, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Behavioral weight loss program

Self-compassion

Nutrition and cooking education

About this trial

This is an interventional treatment trial for Obesity focused on measuring self-compassion, exercise, nutrition, physical activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

The Miriam Hospital's Weight Control and Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Weight loss and self-compassion

Weight loss and nutrition/cooking education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recruitment feasibility will be assessed by the number of participants screened and enrolled

Session attendance will be assessed by calculating the overall session attendance (# of sessions completed/# of sessions possible).

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

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

Secondary Outcome Measures

Percent weight change at 6 months

Percent weight change at 9 months

Full Information

NCT ID

NCT04289636

First Posted

February 27, 2020

Last Updated

August 30, 2021

Sponsor

The Miriam Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04289636

Brief Title

Self-compassion and Nutrition (SCAN) Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

April 9, 2021 (Actual)

Study Completion Date

July 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Weight Loss

Keywords

self-compassion, exercise, nutrition, physical activity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight loss and self-compassion

Arm Type

Experimental

Arm Description

Arm Title

Weight loss and nutrition/cooking education

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Behavioral weight loss program

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Self-compassion

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Nutrition and cooking education

Intervention Description

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.

Primary Outcome Measure Information:

Title

Recruitment feasibility will be assessed by the number of participants screened and enrolled

Description

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

Title

Session attendance will be assessed by calculating the overall session attendance (# of sessions completed/# of sessions possible).

Description

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

Time Frame

6 months

Title

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

Description

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

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Percent weight change at 6 months

Time Frame

6 months after study enrollment

Title

Percent weight change at 9 months

Time Frame

9 months after study enrollment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica L Unick, PhD

Organizational Affiliation

The Miriam Hospital's Weight Control & Diabetes Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Miriam Hospital's Weight Control and Diabetes Research Center

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Self-compassion and Nutrition (SCAN) Study

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