NCT05845866

Brief Summary

This study is a randomized controlled trial to evaluate the effect of an adapted version of the Body Project program among adult women of higher body weight who want to lose weight. The study will evaluate treatment effects on weight and shape concern and explore the impact of intervention on weight loss outcomes.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 21, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

March 30, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

April 26, 2023

Last Update Submit

March 25, 2025

Conditions

Body Image DisturbanceOverweight and ObesityWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight and shape concern

    Assessed using the weight concern and shape concern subscales of the Eating Disorder Examination-Questionnaire. Subscale scores range from 0-6.

    week 4

Secondary Outcomes (2)

  • Momentary Weight and Shape Concern

    week 16, week 28

  • Overeating

    week 16, week 28

Other Outcomes (2)

  • Weight change

    week 4 to week 28

  • Adherence to lifestyle intervention

    week 4 to week 28

Study Arms (2)

Modified Body Project

EXPERIMENTAL

Participants will receive this four week intervention followed by 6 months of behavioral weight management

Behavioral: Modified Body ProjectBehavioral: Lifestyle intervention for weight loss

Facts about obesity, myths about weight loss

ACTIVE COMPARATOR

Participants will receive this four week intervention followed by 6 months of behavioral weight management

Behavioral: Facts about obesity, myths about weight lossBehavioral: Lifestyle intervention for weight loss

Interventions

Modified Body ProjectBEHAVIORAL

The Body Project, an evidence-based body image intervention developed for young women at risk for eating pathology, was adapted for use among adult women with high weight and shape concern and high body weight who want to lose weight.

Modified Body Project
Facts about obesity, myths about weight lossBEHAVIORAL

This intervention is designed to help individuals prepare for weight loss and is focused on facts about obesity, myths about weight loss, and the importance of a varied diet.

Facts about obesity, myths about weight loss
Lifestyle intervention for weight lossBEHAVIORAL

This 24-week behavioral weight management program is based on the Look AHEAD and Diabetes Prevention Program manuals. It is designed to facilitate 7-10% weight loss of initial body weight through dietary and physical activity changes with use of behavioral strategies to support lifestyle changes over time.

Facts about obesity, myths about weight lossModified Body Project

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Body Mass Index between 25-40
  • Eating Disorder Examination-Questionnaire weight concern subscale greater than or equal to 4
  • Eating Disorder Examination-Questionnaire shape concern subscale greater than or equal to 4.25
  • Personal use of cell phone
  • Able to engage in moderate intensity activity
  • Desire for weight loss

You may not qualify if:

  • No eating disorder history
  • Not pregnant
  • Not breastfeeding
  • No childbirth/delivery within 9 months
  • No substance use disorder
  • No weight loss medication or history of bariatric surgery
  • No other weight loss program participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

August 21, 2023

Primary Completion

March 31, 2025

Study Completion

August 31, 2025

Last Updated

March 30, 2025

Record last verified: 2025-02

Locations

US(1)