Health TrialsbyHealthPanel

Craving Network Neurofeedback

ConditionOverweight or Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorYale University

About this trial

This project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues using neurofeedback, to impact their craving and eating behavior.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ages 18 to 60 years

Body mass index >25 kg/m2

>2.37 Food Craving Inventory score

Disqualifiers

Current or past 6 months use of anti-obesity medications

Weight-reduced state defined as >10% weight reduction in the past 6 months.

Nicotine use

Current diagnosis of neurological or psychiatric disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental feedback

    Device

    Participants provided with feedback of target brain activation patterns (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer).

  • Control feedback

    Device

    Participants provided with control (sham, yoked to another participant) feedback (e.g., thermometer) and will be instructed to try to change the feedback (e.g., decrease the thermometer).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: NeurofeedbackExperimental treatment 1 intervention
Group B: Control neurofeedbackSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in craving network strength during transfer runs

Craving network strength will be measured during transfer (i.e., no feedback) runs and compared across scan sessions.

Time frame
Week 1 and 3
2

Change in Food Craving Inventory Mean Score

Food Craving Inventory has 28 items rated 1-5 and overall mean is calculated, range 1-5 with higher score indicating higher craving. FCI will be compared between baseline and 1 month follow-up.

Time frame
Week 1, Week 7
3

Change in Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool Healthy Eating Index (HEI).

ASA-24 HEI is scored 0-100 with 100 indicating healthier diet and composite scores examined to interpret the overall score. HEI will be compared between baseline and 1 month follow-up.

Time frame
Week 1, Week 7
4

Change in craving network strength during resting state runs

Craving network strength will be measured during resting state runs and compared across scan sessions.

Time frame
Week 1 and 3

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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