NCT04289636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

February 27, 2020

Last Update Submit

August 30, 2021

Conditions

ObesityWeight Loss

Keywords

self-compassionexercisenutritionphysical activity

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Percent weight change at 6 months

    6 months after study enrollment

  • Percent weight change at 9 months

    9 months after study enrollment

Study Arms (2)

Weight loss and self-compassion

EXPERIMENTAL

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 programBehavioral: Self-compassion

Weight loss and nutrition/cooking education

ACTIVE COMPARATOR

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 programBehavioral: Nutrition and cooking education

Interventions

Behavioral weight loss programBEHAVIORAL

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.

Weight loss and nutrition/cooking educationWeight loss and self-compassion
Self-compassionBEHAVIORAL

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.

Weight loss and self-compassion
Nutrition and cooking educationBEHAVIORAL

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.

Weight loss and nutrition/cooking education

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • BMI between 40 - 55 kg/m2
  • Female
  • Score high on internalized weight bias

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital's Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

ObesityWeight LossMotor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Jessica L Unick, PhD

    The Miriam Hospital's Weight Control & Diabetes Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

February 27, 2020

First Posted

February 28, 2020

Study Start

September 1, 2020

Primary Completion

April 9, 2021

Study Completion

July 13, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations

US(1)