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Completed

NCT Number: NCT04202133

Neurocognitive Benefits of a Weight Management Program

This study will assess whether weight loss induced through diet and physical activity can change neural responses to high- and low-calorie food images. In addition, it will evaluate whether weight loss can improve neural function when performing the N-back task, a measure of working memory. Findings will address notable gaps in the literature by testing whether a scalable weight loss intervention can help protect and improve neurocognitive functioning and brain health in individuals with obesity. This study will also provide important information about the effects of weight loss on neuroplasticity in brain regions crucial for memory and cognitive functioning, which will help to inform future interventions aimed at promoting brain health.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

The purpose of the present study is to conduct a randomized controlled trial (RCT) to assess the effects of a commercially available weight loss program (WW; formerly Weight Watchers) on neural response to food cues and memory tasks, as well as on structural brain morphology. Participants with obesity will be randomized to either 16 weeks of an in-person, group-based WW program (n=30) or a wait-list control (WLC; n=30). Both groups will have structural and blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) scans at baseline and after the 16-week intervention. Participants will complete the following fMRI tasks: 1) structural scan; 2) food cue task to measure reactivity to high and low-calorie food images and 3) N-back task to measure working memory (i.e., the ability to temporarily hold information available for processing). In addition, participants will complete self-report and behavioral measures of eating behaviors, appetite, physical activity, mood, quality of life, attention and memory at baseline, and weeks 8 and 16.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18-60 years
  • Female
  • BMI>30 kg/m2
  • Eligible female patients will be:
  • Non-pregnant
  • Non-lactating
  • Surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study. Acceptable methods of birth control are: hormonal contraceptives; double barrier method (condom with spermicide or diaphragm with spermicide); intrauterine device; surgical sterility; abstinence; and/or postmenopausal status (defined as at least 2 years without menses).
  • Participants must:
  • Understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent

Exclusion criteria

  • Weight>158.8 kg (350 lbs, due to scanner weight restrictions)
  • Serious medical risk such as type 1 or 2 diabetes, cancer, or recent cardiac event (e.g., heart attack, angioplasty)
  • Untreated thyroid disease or any changes (type or dose) in thyroid medication in the last 6 months
  • Current psychiatric disorder that significantly interferes with daily living
  • Active suicidal ideation
  • Current substance use disorder (current or in remission < 1 year)
  • Presence or history of orthopedic circumstances, metallic inserts, pacemaker, claustrophobia, or other conditions that may interfere with magnetic resonance imaging
  • Participation in a structured weight loss program in the prior 6 months
  • WW member within the past 12 months
  • Use of medications known to induce significant weight loss/gain, including chronic use of oral steroids in the past 3 months
  • Psychiatric hospitalization within the past 6 months
  • Loss of >10 lbs of body weight within the past 3 months
  • History or plans for bariatric surgery
  • Visual, auditory, or other impairment affecting task performance
  • Epilepsy
  • Neurological trauma (e.g., concussion)
  • Inability to attend treatment and/or assessment visits
  • Participant from same household
  • Adherence to specialized diet regimes, such as vegetarian, macrobiotic
  • Lack of capacity to provide informed consent
  • Inability to walk 5 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming)
  • Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study

Treatment and study plan

WW (formerly Weight Watchers)

Behavioral

The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.

Waitlist

Behavioral

The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention

Primary outcomes

  1. Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex

    Time frame: Change from baseline to 16 weeks

    Changes in BOLD fMRI response to high-calorie food images

  2. Reward-based Eating

    Time frame: Change from baseline to 16 weeks

    Changes in scores on the Reward-Based Eating Drive Scale; range of 0-52; higher scores indicate higher reward-related eating

  3. Food Cravings- Trait (Lack of Control Over Eating)

    Time frame: Change from baseline to 16 weeks

    Changes in scores on the Food Cravings Questionnaire- Trait (lack of control over eating), range=6-36, higher scores indicate greater cravings

  4. Food Preference

    Time frame: Change from baseline to 16 weeks

    Changes in scores on the Leeds Food Preference Questionnaire

  5. Eating Behaviors

    Time frame: Change from baseline to 16 weeks

    Changes in scores on the Eating Behaviors Questionnaire (liking for high-calorie foods); visual analog scores ranging from 0-100 with higher scores indicating a worse outcome

  6. Hippocampal Volume

    Time frame: Change from baseline to 16 weeks

    Change in hippocampal volume

  7. BOLD fMRI Response to the N-back Task

    Time frame: Change from baseline to 16 weeks

    Changes in BOLD fMRI response to the N-back task

  8. Eating Behaviors (Low-calorie Foods)

    Time frame: Change from baseline to 16 weeks

    Changes in scores on the Eating Behaviors Questionnaire (liking for low-calorie foods); visual analog scores ranging from 0-100 with higher scores indicating a better outcome

Secondary outcomes

  1. N-back Behavioral Performance

    Time frame: Change from baseline to 16 weeks

    Change in reaction time (seconds) on the N-back task

  2. Percent Weight

    Time frame: Change from baseline to 16 weeks

    Percent weight change

  3. Eating Behavior

    Time frame: Change from baseline to 16 weeks

    Changes in eating behavior as measured by the Eating Inventory (Cognitive restraint, disinhibited eating, and hunger subscales, summed scores, higher values indicate greater restraint/disinhibition/hunger). The cognitive restraint scale includes 21 items (range 0-21). Higher scores demonstrate more awareness of one's eating and success in restricting dietary intake for weight control. The disinhibited eating scale includes 16 items (range 0-16). Higher scores signify more overeating tendencies. The hunger scale has 14 items and higher scores indicate more perceived hunger (range 0-14). Subscales were analyzed separately.

  4. Power of Food

    Time frame: Change from baseline to 16 weeks

    Changes in eating behavior as measured by the Power of Food Scale; higher scores indicate greater hedonic hunger. Range of scores is 1-5

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • WW International Inc

Registry information

Official study title

A Randomized Controlled Trial Examining the Neurocognitive Benefits of a Nationally Available Weight Management Program

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2019
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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