CClinicalTrials.gg
CompletedNCT04771455Updated Sep 19, 2024Results posted

Testing Intervention Strategies for Addressing Obesity and Binge Eating

An interventional study of Behavioral weight loss and Intervention component: Decrease overvaluation of weight and shape in Obesity and Binge Eating, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Obesity
  • Binge Eating
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 81 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Diagnosis for which the study/intervention is not clinically indicated
  • Not currently receiving clinical services for weight management or binge eating
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    Condition 1

    Behavioral weight loss intervention

    Behavioral: Behavioral weight loss

  • Experimental
    Condition 2

    Behavioral weight loss intervention and decrease negative affect

    Behavioral: Behavioral weight loss · Behavioral: Intervention component: Decrease negative affect

  • Experimental
    Condition 3

    Behavioral weight loss intervention and decrease unhealthy weight control practices

    Behavioral: Behavioral weight loss · Behavioral: Intervention component: Decrease unhealthy weight control practices

  • Experimental
    Condition 4

    Behavioral weight loss intervention, decrease unhealthy weight control practices, and decrease negative affect

    Behavioral: Behavioral weight loss · Behavioral: Intervention component: Decrease unhealthy weight control practices · Behavioral: Intervention component: Decrease negative affect

  • Experimental
    Condition 5

    Behavioral weight loss intervention and decrease overvaluation of weight and shape

    Behavioral: Behavioral weight loss · Behavioral: Intervention component: Decrease overvaluation of weight and shape

  • Experimental
    Condition 6

    Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease negative affect

    Behavioral: Behavioral weight loss · Behavioral: Intervention component: Decrease overvaluation of weight and shape · Behavioral: Intervention component: Decrease negative affect

  • Experimental
    Condition 7

    Behavioral weight loss intervention, decrease overvaluation of weight and shape, and decrease unhealthy weight control practices

    Behavioral: Behavioral weight loss · Behavioral: Intervention component: Decrease overvaluation of weight and shape · Behavioral: Intervention component: Decrease unhealthy weight control practices

  • Experimental
    Condition 8

    Behavioral weight loss intervention, decrease overvaluation of weight and shape, decrease unhealthy weight control practices, and decrease negative affect

    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

Interventions

  • BehavioralBehavioral weight loss

    Participants will receive behavioral weight loss intervention

  • BehavioralIntervention component: Decrease overvaluation of weight and shape

    Participants will receive an intervention component to decrease overvaluation of weight and shape

  • BehavioralIntervention component: Decrease unhealthy weight control practices

    Participants will receive an intervention component to decrease unhealthy weight control practices

  • BehavioralIntervention component: Decrease negative affect

    Participants will receive an intervention component to decrease negative affect

06

What researchers measure

Primary outcomes

  1. Weight

    Changes in weight

    Time frame: Measured at baseline, post-intervention (16-weeks)

  2. Binge Eating Episodes

    Changes in episodes of binge eating (past 28 days)

    Time frame: Measured at baseline, post-intervention (16-weeks)

07

Results

Posted Sep 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneCondition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8
Started1010101011101010
Completed9989118109
Not completed11210201

Outcome measures

PrimaryWeight

Changes in weight

Time frame:
Measured at baseline, post-intervention (16-weeks)
Reported as:
Mean · pounds
Weight
poundsOvervaluation of Weight/Shape (Yes)Overvaluation of Weight/Shape (no)Unhealthy Weight Control Practices (Yes)Unhealthy Weight Control Practices (no)Negative Affect (Yes)Negative Affect (no)
Weight4.2 ± 21.96.9 ± 21.34.7 ± 22.66.3 ± 20.78.5 ± 27.72.7 ± 12.6
PrimaryBinge Eating Episodes

Changes in episodes of binge eating (past 28 days)

Time frame:
Measured at baseline, post-intervention (16-weeks)
Reported as:
Mean · Change in number of episodes
Binge Eating Episodes
Change in number of episodesOvervaluation of Weight/Shape (Yes)Overvaluation of Weight/Shape (no)Unhealthy Weight Control Practices (Yes)Unhealthy Weight Control Practices (no)Negative Affect (Yes)Negative Affect (no)
Binge Eating Episodes8.1 ± 10.910.1 ± 13.76.9 ± 8.511.2 ± 15.09.8 ± 11.18.4 ± 13.5

Adverse events

Collected over 7 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Condition 10/10 (0%)0/10 (0%)0/10 (0%)
Condition 20/10 (0%)0/10 (0%)0/10 (0%)
Condition 30/10 (0%)0/10 (0%)0/10 (0%)
Condition 40/10 (0%)0/10 (0%)0/10 (0%)
Condition 50/11 (0%)0/11 (0%)0/11 (0%)
Condition 60/10 (0%)0/10 (0%)0/10 (0%)
Condition 70/10 (0%)0/10 (0%)0/10 (0%)
Condition 80/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Total
Mean44.1 ± 17.636.9 ± 12.549.5 ± 10.737.5 ± 18.248.1 ± 15.341.2 ± 13.542.1 ± 15.547.3 ± 17.343.4 ± 15.3
Sex: Female, Male
Sex: Female, Male(Participants)Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Total
Female97871067862
Male1323143219
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Total
Hispanic or Latino3233131117
Not Hispanic or Latino78771079964
Unknown or Not Reported000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Condition 1Condition 2Condition 3Condition 4Condition 5Condition 6Condition 7Condition 8Total
American Indian or Alaska Native000010001
Asian220001016
Native Hawaiian or Other Pacific Islander000000000
Black or African American3423844533
White5464246435
More than one race001301005
Unknown or Not Reported001000001
08

Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
09

References and documents

Study documents

  • Study protocol · Feb 14, 2022
  • Statistical analysis plan · Dec 20, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04771455
Lead sponsor
Northwestern University
Responsible party
Andrea Graham (Assistant Professor, Northwestern University) — Principal investigator
First posted
Feb 25, 2021
Start date
Feb 16, 2021
Primary completion
Nov 30, 2022
Completion
Nov 30, 2022
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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