Self-compassion and Nutrition (SCAN) Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Weight Loss

Intervention / Treatment
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* Behavioral: Behavioral weight loss program
* Behavioral: Self-compassion
* Behavioral: Nutrition and cooking education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight loss and self-compassion<br>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<br>* 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.<br>Behavioral: Self-compassion<br>* 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.<br>|
| Active Comparator: Weight loss and nutrition/cooking education<br>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<br>* 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.<br>Behavioral: Nutrition and cooking education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight change at 6 months |  | 6 months after study enrollment | 
| Percent weight change at 9 months |  | 9 months after study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-compassion, exercise, nutrition, physical activity