Body Image DisturbanceNCT05845866
Targeting Weight and Shape Concern Among Women with High Body Weight
A study testing Modified Body Project, Facts about obesity, myths about weight loss and Lifestyle intervention for weight loss in people with Body Image Disturbance and Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image Disturbance, Overweight and Obesity, Weight Loss
- What is being tested?
- Modified Body Project, Facts about obesity, myths about weight loss and Lifestyle intervention for weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Randomized Controlled Pilot Trial Targeting Weight and Shape Concern Among Women Enrolled in Behavioral Weight Management
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.
Read the 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).
- Conditions
- Body Image Disturbance, Overweight and Obesity, Weight Loss
- Being tested
- Modified Body Project, Facts about obesity, myths about weight loss, Lifestyle intervention for weight loss
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Body ProjectBehavioural
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.
Facts about obesity, myths about weight lossBehavioural
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.
Lifestyle intervention for weight lossBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Modified Body Project | Experimental | Participants will receive this four week intervention followed by 6 months of behavioral weight management Receives: Behavioral: Modified Body Project; Behavioral: 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 Receives: Behavioral: Facts about obesity, myths about weight loss; Behavioral: Lifestyle intervention for weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 4
Secondary outcomes (2)
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.
Measured: week 16, week 28
Overeating
Ecological momentary assessment will be used to assess overeating in daily life.
Measured: week 16, week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start21 Aug 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Image DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845866
- Sponsor's protocol ID
- K23DK124578
- Status last verified
- Feb 2025
- First submitted
- 26 Apr 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Trial Targeting Weight and Shape Concern Among Women Enrolled in Behavioral Weight Management
- ClinicalTrials.gov ID
- NCT05845866
- Acronym / sponsor ID
- K23DK124578
- Conditions
- Body Image Disturbance, Overweight and Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Modified Body Project | Experimental | Behavioral: Modified Body Project, Behavioral: Lifestyle intervention for weight lossParticipants will receive this four week intervention followed by 6 months of behavioral weight management |
| Facts about obesity, myths about weight loss | Active comparator | Behavioral: Facts about obesity, myths about weight loss, Behavioral: Lifestyle intervention for weight lossParticipants will receive this four week intervention followed by 6 months of behavioral weight management |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- No eating disorder history
- Not pregnant
- Not breastfeeding
- No childbirth/delivery within 9 months
- No substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Body ProjectThe 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. | Behavioural | Modified Body Project |
| Facts about obesity, myths about weight lossThis 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. | Behavioural | Facts about obesity, myths about weight loss |
| Lifestyle intervention for weight lossThis 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. | Behavioural | Facts about obesity, myths about weight loss, Modified Body Project |
Primary outcome
Weight and shape concern
Time frame: week 4
Assessed using the weight concern and shape concern subscales of the Eating Disorder Examination-Questionnaire. Subscale scores range from 0-6.
2 secondary outcomes
Momentary Weight and Shape Concern
Time frame: week 16, week 28
Overeating
Time frame: week 16, week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Body Project, Facts about obesity, myths about weight loss and Lifestyle intervention for weight loss in people with Body Image Disturbance and Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight and shape concern (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.