Self-compassion and Nutrition (SCAN) Study

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289636
• Other study ID #: 1569066
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: July 13, 2021

Study information

• Verified date: August 2021
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 13, 2021
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The Miriam Hospital's Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment feasibility will be assessed by the number of participants screened and enrolled	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
Primary	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	6 months
Primary	Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit	Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit	9 months
Secondary	Percent weight change at 6 months		6 months after study enrollment
Secondary	Percent weight change at 9 months		9 months after study enrollment