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Targeting Weight and Shape Concern Among Women With High Body Weight

Primary Purpose

Body Image Disturbance, Overweight and Obesity, Weight Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified Body Project
Facts about obesity, myths about weight loss
Lifestyle intervention for weight loss
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Image Disturbance

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Modified Body Project

    Facts about obesity, myths about weight loss

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Momentary Weight and Shape Concern
    Ecological momentary assessment will be used to assess in-the-moment thoughts about weight and shape on a 0-10 scale.
    Overeating
    Ecological momentary assessment will be used to assess overeating in daily life.

    Full Information

    First Posted
    April 26, 2023
    Last Updated
    April 26, 2023
    Sponsor
    The Miriam Hospital
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05845866
    Brief Title
    Targeting Weight and Shape Concern Among Women With High Body Weight
    Official Title
    Randomized Controlled Pilot Trial Targeting Weight and Shape Concern Among Women Enrolled in Behavioral Weight Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Miriam Hospital
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    The objective of this study is to conduct a randomized controlled pilot trial to test the effects of a 28-week treatment protocol that combines a modified body image intervention (The Body Project: weeks 1-4) with a 6-month standard behavioral weight management treatment (weeks 5-28). The combined protocol will be evaluated in comparison to a control group that receives an education only program during weeks 1-4 followed by the same 6-month weight management treatment. It will be tested among women with high body weight who report High Weight and Shape Concern and would like to lose weight. The goals of the study are: To evaluate effects of a manualized intervention on Weight and Shape Concern prior to starting weight management. To evaluate the effects of the modified Body Project intervention on momentary weight/shape-related thoughts and overeating episodes during behavioral weight management. To conduct exploratory analyses comparing effects of the two treatment conditions on weight loss and other weight-related behaviors (e.g., exercise, adherence to self-monitoring).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Body Image Disturbance, Overweight and Obesity, Weight Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Modified Body Project
    Arm Type
    Experimental
    Arm Description
    Participants will receive this four week intervention followed by 6 months of behavioral weight management
    Arm Title
    Facts about obesity, myths about weight loss
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive this four week intervention followed by 6 months of behavioral weight management
    Intervention Type
    Behavioral
    Intervention Name(s)
    Modified Body Project
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Facts about obesity, myths about weight loss
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle intervention for weight loss
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Weight and shape concern
    Description
    Assessed using the weight concern and shape concern subscales of the Eating Disorder Examination-Questionnaire. Subscale scores range from 0-6.
    Time Frame
    week 4
    Secondary Outcome Measure Information:
    Title
    Momentary Weight and Shape Concern
    Description
    Ecological momentary assessment will be used to assess in-the-moment thoughts about weight and shape on a 0-10 scale.
    Time Frame
    week 16, week 28
    Title
    Overeating
    Description
    Ecological momentary assessment will be used to assess overeating in daily life.
    Time Frame
    week 16, week 28
    Other Pre-specified Outcome Measures:
    Title
    Weight change
    Description
    Percent weight change will be calculated from weight at the start of weight loss treatment to program completion.
    Time Frame
    week 4 to week 28
    Title
    Adherence to lifestyle intervention
    Description
    Adherence to exercise, dietary tracking, and self-weighing will be monitored throughout weight loss treatment.
    Time Frame
    week 4 to week 28

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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

    12. IPD Sharing Statement

    Learn more about this trial

    Targeting Weight and Shape Concern Among Women With High Body Weight

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