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NCT02977403

Mobile Attention Retraining in Overweight Female Adolescents

Completed NA Results posted Last updated 31 May 2025
What this trial tests

NA trial testing Attention Bias Retraining in Obesity in 82 participants. Completed in 13 November 2024.

Timeline
10 February 2017
Primary endpoint
8 June 2023
13 November 2024

Quick facts

Lead sponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment82
Start date10 February 2017
Primary completion8 June 2023
Estimated completion13 November 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Who can join

Adults 12 to 21, female only, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Food-cue Visual Probe Task Attention Bias (AB) Reaction Time Primary · 2-weeks

AB was obtained for each stimulus pairing (High-Palatability Food \[HPF\] minus Non-Food \[NF\] image, Low-Palatability Food \[LPF\] minus NF image, HPF minus LPF image). Trials where the probe appeared behind the more food-salient cue (e.g., a HPF image, or LPF vs NF image) were considered congruent trials. Trials where the probe appeared behind the less salient cue (e.g., NF image, or LPF image when the other image was a HPF image) were considered incongruent trials. The average reaction time during incongruent trials was subtracted from reaction time during during congruent trials. Positive

GroupValue95% CI
AB Retraining1.85-8.44 – 12.13
Control Sham4.27-6.25 – 14.80
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Left Hemisphere During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Change in beta band (13-35 Hz) oscillatory power at the caudate left hemisphere during attention capture (0-250ms following stimulus). Oscillatory power was normalized as per NeuroImage 39 (2008) pp 1788-1802, by estimating noise power as ρθ = WθTΣWθ (where Wθ is a (M × 1) column vector of weighting parameters that are tuned specifically to the location and orientation represented by θ, Σ represents the noise covariance matrix and ρθ is the beamformer-projected sensor noise power at the location and orientation θ). Within each stimuli-pairing and attention phase, oscillatory power during the i

GroupValue95% CI
AB Control0.010-0.027 – 0.048
AB Retraining.021-0.014 – 0.056
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Right Hemisphere During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudate right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

GroupValue95% CI
AB Control0.032-0.011 – 0.075
AB Retraining0.023-0.017 – 0.063
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Left Hemisphere During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

GroupValue95% CI
AB Control-0.007-0.055 – 0.041
AB Retraining0.038-0.006 – 0.083
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Right Hemisphere During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

GroupValue95% CI
AB Control0.028-0.022 – 0.078
AB Retraining0.009-0.037 – 0.056
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Left Hemisphere During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

GroupValue95% CI
AB Control-0.013-0.056 – 0.030
AB Retraining0.0460.006 – 0.086
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Right Hemisphere During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

GroupValue95% CI
AB Control0.017-0.029 – 0.063
AB Retraining0.020-0.022 – 0.063
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex left hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

GroupValue95% CI
AB Control0.035-0.009 – 0.078
AB Retraining-0.041-0.081 – -0.001
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex right hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

GroupValue95% CI
AB Control0.0530.011 – 0.095
AB Retraining0.002-0.037 – 0.041
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Left Hemisphere - During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex left hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

GroupValue95% CI
AB Control0.012-0.030 – 0.055
AB Retraining0.012-0.027 – 0.051
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

GroupValue95% CI
AB Control0.002-0.034 – 0.039
AB Retraining-0.024-0.058 – 0.010
Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus) Primary · 2-weeks

Neural activity during a food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

GroupValue95% CI
AB Control-0.010-0.050 – 0.030
AB Retraining0.026-0.011 – 0.063

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AB Retraining
Serious: 0/32 (0%)
Deaths: 0/32
Control Sham
Serious: 0/36 (0%)
Deaths: 0/36
Other adverse events (3 terms — click to expand)

ReactionSystemAB RetrainingControl Sham
NauseaGastrointestinal disorders
HeadacheMusculoskeletal and connective tissue disorders
Neck PainMusculoskeletal and connective tissue disorders

Data from ClinicalTrials.gov NCT02977403 adverse events section.

Sponsor's own description

Background: People are constantly exposed to unhealthy foods. Some studies of adults show that training attention away from unhealthy foods might reduce overeating. Researchers want to see what happens in the brain when teens train their attention away from food through a program on a smartphone. Objective: To study the relationship between eating patterns, body weight, and how the brain reacts to different images. Eligibility: Right-handed females ages 12-17 who are overweight (Body Mass Index at or above the 85th percentile for age). Design: Participants will have 6 visits over about 8 months. Visit 1: participants will be screened with: Height, weight, blood pressure, and waist size measurements Medical history Physical exam Urine sample DXA scan. Participants will lie on a table while a very small dose of x-rays passes through the body. Questions about their general health, social and psychological functioning, and eating habits Parents or guardians of minor participants will answer questions about their child s functioning and demographic data. Before visits 2-6, participants will not eat or drink for about 12 hours. These visits will include some or all of these procedures: Blood drawn MRI scan. Participants will lie on a stretcher that slides in and out of a metal cylinder in a strong magnetic field. A device will be placed over the head. Meals provided. Participants will fill out rating forms. Simple thinking tasks A cone containing magnetic field detectors placed onto the head Medical history Physical exam Urine sample Participants will be assigned to a 2-week smartphone program that involves looking at pictures. Participants will complete short tasks and answer some questions about their eating habits and mood on the smartphone.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Examination of the Interaction between Parental Military-Status and Race among Non-Hispanic Black and Non-Hispanic White Adolescents with Overweight/Obesity.
    Higgins Neyland MK, Shank LM, Lavender JM, Burke NL, et al · · 2022 · cited 3× · PMID 35238941 · DOI 10.1093/jpepsy/jsac008
  2. A Pilot Randomized Control Trial Testing a Smartphone-Delivered Food Attention Retraining Program in Adolescent Girls with Overweight or Obesity.
    Parker MN, Bloomer BF, Stout JD, Byrne ME, et al · · 2024 · cited 2× · PMID 39458453 · DOI 10.3390/nu16203456
  3. Associated features of pediatric loss-of-control eating severity during a laboratory-based feeding paradigm.
    Parker MN, LeMay-Russell S, Loch LK, Bloomer BF, et al · · 2023 · cited 1× · PMID 37536224 · DOI 10.1016/j.eatbeh.2023.101790
  4. Youth's energy intake during a laboratory-based loss-of-control eating paradigm: Associations with reported current dieting.
    Parker MN, Moursi NA, Adekola PE, Bloomer BF, et al · · 2024 · PMID 38640597 · DOI 10.1016/j.eatbeh.2024.101877
  5. Neural underpinnings of threat bias in relation to loss-of-control eating behaviors among adolescent girls with high weight.
    Byrne ME, Tanofsky-Kraff M, Liuzzi L, Holroyd T, et al · · 2023 · PMID 37965354 · DOI 10.3389/fpsyt.2023.1276300

Verify or expand the search:

Other recruiting trials for Obesity

Currently open trials in the same condition.

Other Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) trials

Trials by the same sponsor.

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