Clinical trial NCT04289636: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: self-compassion
exercise
nutrition
physical activity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recruitment feasibility will be assessed by the number of participants screened and enrolled
timeFrame: At the end of the study, up to 9 months post-baseline
measure: Session attendance will be assessed by calculating the overall session attendance (# of sessions completed/# of sessions possible).
timeFrame: 6 months
measure: Acceptability of the intervention (retention) will be determined by the percentage of participants completing the 9-month assessment visit
timeFrame: 9 months
Secondary outcomes:
measure: Percent weight change at 6 months
timeFrame: 6 months after study enrollment
measure: Percent weight change at 9 months
timeFrame: 9 months after study enrollment
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital's Weight Control & Diabetes Research Center
name: Jessica L Unick, PhD
role: PRINCIPAL_INVESTIGATOR
References: