ObesityNCT04771455

Testing Intervention Strategies for Addressing Obesity and Binge Eating

A study testing Behavioral weight loss, Intervention component: Decrease overvaluation of weight and shape and Intervention component: Decrease negative affect in people with Obesity and Binge Eating, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to conduct a randomized pilot trial of a mobile intervention that targets obesity and binge eating. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity, Binge Eating
What is being tested?: Behavioral weight loss, Intervention component: Decrease overvaluation of weight and shape and Intervention component: Decrease negative affect
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteUnited States
Study dates: 16 Feb 2021to 30 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults age 18 years or older
Obesity (BMI ≥30)
Recurrent binge eating (≥12 episodes in the past 3 months)
Interested in losing weight and reducing binge eating
Willing to use a mobile application
Has a smartphone with Internet access and capacity for calls and text messaging

Show all 10Show fewer

Has a valid email address
Has access to a scale
Not pregnant
English-speaking

Who cannot join

Diagnosis for which the study/intervention is not clinically indicated
Not currently receiving clinical services for weight management or binge eating

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

The purpose of this study is to conduct a randomized pilot trial of a mobile intervention that targets obesity and binge eating.

Conditions: Obesity, Binge Eating
Being tested: Behavioral weight loss, Intervention component: Decrease overvaluation of weight and shape, Intervention component: Decrease unhealthy weight control practices, Intervention component: Decrease negative affect
Medical subject headings: Obesity, Bulimia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral weight lossBehavioural
Participants will receive behavioral weight loss intervention
Intervention component: Decrease overvaluation of weight and shapeBehavioural
Participants will receive an intervention component to decrease overvaluation of weight and shape
Intervention component: Decrease unhealthy weight control practicesBehavioural
Participants will receive an intervention component to decrease unhealthy weight control practices
Intervention component: Decrease negative affectBehavioural
Participants will receive an intervention component to decrease negative affect

Study groups in NCT04771455
Study group	Role	What they receive
Condition 1	Experimental	Behavioral weight loss intervention Receives: Behavioral: Behavioral weight loss
Condition 2	Experimental	Behavioral weight loss intervention and decrease negative affect Receives: Behavioral: Behavioral weight loss; Behavioral: Intervention component: Decrease negative affect
Condition 3	Experimental	Behavioral weight loss intervention and decrease unhealthy weight control practices Receives: Behavioral: Behavioral weight loss; Behavioral: Intervention component: Decrease unhealthy weight control practices
Condition 4	Experimental	Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect Receives: Behavioral: Behavioral weight loss; Behavioral: Intervention component: Decrease unhealthy weight control practices; Behavioral: Intervention component: Decrease negative affect
Condition 5	Experimental	Behavioral weight loss intervention and decrease overvaluation of weight and shape Receives: Behavioral: Behavioral weight loss; Behavioral: Intervention component: Decrease overvaluation of weight and shape
Condition 6	Experimental	Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect Receives: Behavioral: Behavioral weight loss; Behavioral: Intervention component: Decrease overvaluation of weight and shape; Behavioral: Intervention component: Decrease negative affect
Condition 7	Experimental	Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices Receives: Behavioral: Behavioral weight loss; Behavioral: Intervention component: Decrease overvaluation of weight and shape; Behavioral: Intervention component: Decrease unhealthy weight control practices
Condition 8	Experimental	Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect Receives: Behavioral: Behavioral weight loss; Behavioral: Intervention component: Decrease overvaluation of weight and shape; Behavioral: Intervention component: Decrease unhealthy weight control practices; Behavioral: Intervention component: Decrease negative affect

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight
Changes in weight
Measured: Measured at baseline, post-intervention (16-weeks)
Binge Eating Episodes
Changes in episodes of binge eating (past 28 days)
Measured: Measured at baseline, post-intervention (16-weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 202130 Nov 2022

First posted25 Feb 2021
Study start16 Feb 2021
Primary completion30 Nov 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
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: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04771455
Sponsor's protocol ID: STU00208056
Status last verified: Sep 2024
First submitted: 16 Feb 2021
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing Intervention Strategies for Addressing Obesity and Binge Eating
ClinicalTrials.gov ID: NCT04771455
Acronym / sponsor ID: STU00208056
Conditions: Obesity, Binge Eating
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: 16 Feb 2021 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 25 Feb 2021 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to conduct a randomized pilot trial of a mobile intervention that targets obesity and binge eating.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 8

Arm	Type	Receives
Condition 1	Experimental	Behavioral: Behavioral weight lossBehavioral weight loss intervention
Condition 2	Experimental	Behavioral: Behavioral weight loss, Behavioral: Intervention component: Decrease negative affectBehavioral weight loss intervention and decrease negative affect
Condition 3	Experimental	Behavioral: Behavioral weight loss, Behavioral: Intervention component: Decrease unhealthy weight control practicesBehavioral weight loss intervention and decrease unhealthy weight control practices
Condition 4	Experimental	Behavioral: Behavioral weight loss, Behavioral: Intervention component: Decrease unhealthy weight control practices, Behavioral: Intervention component: Decrease negative affectBehavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect
Condition 5	Experimental	Behavioral: Behavioral weight loss, Behavioral: Intervention component: Decrease overvaluation of weight and shapeBehavioral weight loss intervention and decrease overvaluation of weight and shape
Condition 6	Experimental	Behavioral: Behavioral weight loss, Behavioral: Intervention component: Decrease overvaluation of weight and shape, Behavioral: Intervention component: Decrease negative affectBehavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect
Condition 7	Experimental	Behavioral: Behavioral weight loss, Behavioral: Intervention component: Decrease overvaluation of weight and shape, Behavioral: Intervention component: Decrease unhealthy weight control practicesBehavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices
Condition 8	Experimental	Behavioral: Behavioral weight loss, Behavioral: Intervention component: Decrease overvaluation of weight and shape, Behavioral: Intervention component: Decrease unhealthy weight control practices, Behavioral: Intervention component: Decrease negative affectBehavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Adults age 18 years or older
Obesity (BMI ≥30)
Recurrent binge eating (≥12 episodes in the past 3 months)
Interested in losing weight and reducing binge eating
Willing to use a mobile application

Key exclusion criteria (2 listed)

Diagnosis for which the study/intervention is not clinically indicated
Not currently receiving clinical services for weight management or binge eating

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
Behavioral weight lossParticipants will receive behavioral weight loss intervention	Behavioural	Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8
Intervention component: Decrease overvaluation of weight and shapeParticipants will receive an intervention component to decrease overvaluation of weight and shape	Behavioural	Condition 5, Condition 6, Condition 7, Condition 8
Intervention component: Decrease unhealthy weight control practicesParticipants will receive an intervention component to decrease unhealthy weight control practices	Behavioural	Condition 3, Condition 4, Condition 7, Condition 8
Intervention component: Decrease negative affectParticipants will receive an intervention component to decrease negative affect	Behavioural	Condition 2, Condition 4, Condition 6, Condition 8

Primary outcome

Weight
Time frame: Measured at baseline, post-intervention (16-weeks)
Changes in weight
Binge Eating Episodes
Time frame: Measured at baseline, post-intervention (16-weeks)
Changes in episodes of binge eating (past 28 days)

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Condition 1	10	9
Condition 2	10	9
Condition 3	10	8
Condition 4	10	9
Condition 5	11	11
Condition 6	10	8
Condition 7	10	10
Condition 8	10	9

Primary outcome: Weight

Time frame: Measured at baseline, post-intervention (16-weeks). Mean (Standard Deviation). Unit: pounds

Measure	Overvaluation of Weight/Shape (Yes) n = 41	Overvaluation of Weight/Shape (no) n = 40	Unhealthy Weight Control Practices (Yes) n = 40	Unhealthy Weight Control Practices (no) n = 41	Negative Affect (Yes) n = 40	Negative Affect (no) n = 41
Value	4.2 (21.9)	6.9 (21.3)	4.7 (22.6)	6.3 (20.7)	8.5 (27.7)	2.7 (12.6)

Primary outcome: Binge Eating Episodes

Time frame: Measured at baseline, post-intervention (16-weeks). Mean (Standard Deviation). Unit: Change in number of episodes

Measure	Overvaluation of Weight/Shape (Yes) n = 41	Overvaluation of Weight/Shape (no) n = 40	Unhealthy Weight Control Practices (Yes) n = 40	Unhealthy Weight Control Practices (no) n = 41	Negative Affect (Yes) n = 40	Negative Affect (no) n = 41
Value	8.1 (10.9)	10.1 (13.7)	6.9 (8.5)	11.2 (15.0)	9.8 (11.1)	8.4 (13.5)

Adverse events

Time frame: 7 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Condition 1	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Condition 2	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Condition 3	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Condition 4	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Condition 5	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Condition 6	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Condition 7	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Condition 8	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
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Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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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?

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 10 inclusion and 2 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: Measured at baseline, post-intervention (16-weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04771455.

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 19 Sep 2024.