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Completed

NCT Number: NCT04289636

Self-compassion and Nutrition (SCAN) Study

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.

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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

behavioral weight loss program

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Percent weight change at 6 months

    Time frame: 6 months after study enrollment

  2. Percent weight change at 9 months

    Time frame: 9 months after study enrollment

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 28, 2020
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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