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Neurocognitive Benefits of a Weight Management Program

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
WW (formerly Weight Watchers)
Waitlist
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring obesity, weight loss, neuroimaging, fMRI, behavioral obesity treatment

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

WW (formerly Weight Watchers)

Waitlist Control

Arm Description

16-weeks of the group-based WW program

16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program

Outcomes

Primary Outcome Measures

Blood oxygen level-dependent (BOLD) response to food cues
Changes in BOLD fMRI response to high- and low-calorie food images
Reward-based eating
Changes in scores on the Reward-Based Eating Drive Scale; range of 0-52; higher scores indicate higher reward-related eating
Food cravings
Changes in scores on the Food Cravings Questionnaire; summed scores for subscales; higher scores indicate greater cravings
Food preference
Changes in scores on the Leeds Food Preference Questionnaire
Eating behaviors
Changes in scores on the Eating Behaviors Questionnaire; visual analog scores
Hippocampal volume
Change in hippocampal volume
BOLD fMRI response to the N-back task
Changes in BOLD fMRI response to the N-back task

Secondary Outcome Measures

N-back behavioral performance
Change in reaction time (seconds) on the N-back task
Accuracy on N-back Task
Accuracy (percent of correct responses) on the N-back task
Percent Weight
Percent weight change
Blood Pressure
Change in systolic and diastolic blood pressure
Waist Circumference
Change in waist circumference
Executive Functioning
Changes in executive functioning as measured by the National Institutes of Health Toolbox-Cognitive Function Battery
Mood
Changes in mood as measured by the Beck Depression Inventory-II; range 0-63; higher scores indicate greater depressive symptoms
Eating Behavior
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)
Binge eating and weight control behaviors
Changes in eating behavior as measured by the Questionnaire on Weight and Eating Pattern-5
Power of Food
Changes in eating behavior as measured by the Power of Food Scale; higher scores indicate greater hedonic hunger
Palatable Eating Motives
Changes in eating behavior as measured by the Palatable Eating Motives- Revised; total score and subscale scores (coping, reward enhancement, conformity, social motives) with higher scores indicating greater consumption of tasty foods for non-metabolic reasons
Portion sizes
Changes in eating behavior as measured by the Modified Eating Patterns Questionnaire; higher scores indicate higher thresholds for perceived portions
Disordered Eating Behaviors and Thoughts
Changes in disordered eating behaviors and thoughts as measured by the Eating Disorder Examination Questionnaire (Global score and subscales; range 0-6 with higher scores indicating greater psychopathology; frequency of disordered eating behaviors)
Stress
Changes in stress as measured by the Perceived Stress Scale; range of 0-40 with higher scores indicating more stress
Perceived Nutrition Environment
Changes in perceived nutrition environment as measured by the Perceived Nutrition Environment
Resilience
Changes in resilience as measured by the Brief Resilience Scale; range of 6-30; greater scores indicate more resilience
Food Addiction
Changes in food addiction as measured by the Yale Food Addiction Scale 2.0; greater scores indicate greater food addiction symptoms
Physical Activity
Changes in physical activity as measured by the Paffenbarger Physical Activity Questionnaire
Generic Quality of Life
Changes in generic quality of life as measured by the Short Form-36; total and subscale scores; higher scores indicate better quality of life
Weight-related Quality of Life
Changes in weight-related quality of life as measured by Impact of Weight on Quality of Life-Lite; total score and 5 subscales; t-scores ranging from 0 (low) to 100 (better)
Self-regulation
Changes in self-regulation as measured by the Index of Self-Regulation; higher scores indicate greater self-regulation
Inhibition
Changes in inhibition as measured by the Behavioral Avoidance/Inhibition Scales; drive, fun seeking, reward responsiveness, inhibition; higher scores
Adherence
Changes in adherence as measured by the number of sessions attended and the number of self-monitoring records completed

Full Information

First Posted
December 3, 2019
Last Updated
July 27, 2021
Sponsor
University of Pennsylvania
Collaborators
Weight Watchers International
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1. Study Identification

Unique Protocol Identification Number
NCT04202133
Brief Title
Neurocognitive Benefits of a Weight Management Program
Official Title
A Randomized Controlled Trial Examining the Neurocognitive Benefits of a Nationally Available Weight Management Program
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
April 2, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Weight Watchers International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
obesity, weight loss, neuroimaging, fMRI, behavioral obesity treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WW (formerly Weight Watchers)
Arm Type
Experimental
Arm Description
16-weeks of the group-based WW program
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program
Intervention Type
Behavioral
Intervention Name(s)
WW (formerly Weight Watchers)
Intervention Description
The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist
Intervention Description
The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention
Primary Outcome Measure Information:
Title
Blood oxygen level-dependent (BOLD) response to food cues
Description
Changes in BOLD fMRI response to high- and low-calorie food images
Time Frame
Change from baseline to 16 weeks
Title
Reward-based eating
Description
Changes in scores on the Reward-Based Eating Drive Scale; range of 0-52; higher scores indicate higher reward-related eating
Time Frame
Change from baseline to 16 weeks
Title
Food cravings
Description
Changes in scores on the Food Cravings Questionnaire; summed scores for subscales; higher scores indicate greater cravings
Time Frame
Change from baseline to 16 weeks
Title
Food preference
Description
Changes in scores on the Leeds Food Preference Questionnaire
Time Frame
Change from baseline to 16 weeks
Title
Eating behaviors
Description
Changes in scores on the Eating Behaviors Questionnaire; visual analog scores
Time Frame
Change from baseline to 16 weeks
Title
Hippocampal volume
Description
Change in hippocampal volume
Time Frame
Change from baseline to 16 weeks
Title
BOLD fMRI response to the N-back task
Description
Changes in BOLD fMRI response to the N-back task
Time Frame
Change from baseline to 16 weeks
Secondary Outcome Measure Information:
Title
N-back behavioral performance
Description
Change in reaction time (seconds) on the N-back task
Time Frame
Change from baseline to 16 weeks
Title
Accuracy on N-back Task
Description
Accuracy (percent of correct responses) on the N-back task
Time Frame
Change from baseline to 16 weeks
Title
Percent Weight
Description
Percent weight change
Time Frame
Change from baseline to 16 weeks
Title
Blood Pressure
Description
Change in systolic and diastolic blood pressure
Time Frame
Change from baseline to 16 weeks
Title
Waist Circumference
Description
Change in waist circumference
Time Frame
Change from baseline to 16 weeks
Title
Executive Functioning
Description
Changes in executive functioning as measured by the National Institutes of Health Toolbox-Cognitive Function Battery
Time Frame
Change from baseline to 16 weeks
Title
Mood
Description
Changes in mood as measured by the Beck Depression Inventory-II; range 0-63; higher scores indicate greater depressive symptoms
Time Frame
Change from baseline to 16 weeks
Title
Eating Behavior
Description
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)
Time Frame
Change from baseline to 16 weeks
Title
Binge eating and weight control behaviors
Description
Changes in eating behavior as measured by the Questionnaire on Weight and Eating Pattern-5
Time Frame
Change from baseline to 16 weeks
Title
Power of Food
Description
Changes in eating behavior as measured by the Power of Food Scale; higher scores indicate greater hedonic hunger
Time Frame
Change from baseline to 16 weeks
Title
Palatable Eating Motives
Description
Changes in eating behavior as measured by the Palatable Eating Motives- Revised; total score and subscale scores (coping, reward enhancement, conformity, social motives) with higher scores indicating greater consumption of tasty foods for non-metabolic reasons
Time Frame
Change from baseline to 16 weeks
Title
Portion sizes
Description
Changes in eating behavior as measured by the Modified Eating Patterns Questionnaire; higher scores indicate higher thresholds for perceived portions
Time Frame
Change from baseline to 16 weeks
Title
Disordered Eating Behaviors and Thoughts
Description
Changes in disordered eating behaviors and thoughts as measured by the Eating Disorder Examination Questionnaire (Global score and subscales; range 0-6 with higher scores indicating greater psychopathology; frequency of disordered eating behaviors)
Time Frame
Change from baseline to 16 weeks
Title
Stress
Description
Changes in stress as measured by the Perceived Stress Scale; range of 0-40 with higher scores indicating more stress
Time Frame
Change from baseline to 16 weeks
Title
Perceived Nutrition Environment
Description
Changes in perceived nutrition environment as measured by the Perceived Nutrition Environment
Time Frame
Change from baseline to 16 weeks
Title
Resilience
Description
Changes in resilience as measured by the Brief Resilience Scale; range of 6-30; greater scores indicate more resilience
Time Frame
Change from baseline to 16 weeks
Title
Food Addiction
Description
Changes in food addiction as measured by the Yale Food Addiction Scale 2.0; greater scores indicate greater food addiction symptoms
Time Frame
Change from baseline to 16 weeks
Title
Physical Activity
Description
Changes in physical activity as measured by the Paffenbarger Physical Activity Questionnaire
Time Frame
Change from baseline to 16 weeks
Title
Generic Quality of Life
Description
Changes in generic quality of life as measured by the Short Form-36; total and subscale scores; higher scores indicate better quality of life
Time Frame
Change from baseline to 16 weeks
Title
Weight-related Quality of Life
Description
Changes in weight-related quality of life as measured by Impact of Weight on Quality of Life-Lite; total score and 5 subscales; t-scores ranging from 0 (low) to 100 (better)
Time Frame
Change from baseline to 16 weeks
Title
Self-regulation
Description
Changes in self-regulation as measured by the Index of Self-Regulation; higher scores indicate greater self-regulation
Time Frame
Change from baseline to 16 weeks
Title
Inhibition
Description
Changes in inhibition as measured by the Behavioral Avoidance/Inhibition Scales; drive, fun seeking, reward responsiveness, inhibition; higher scores
Time Frame
Change from baseline to 16 weeks
Title
Adherence
Description
Changes in adherence as measured by the number of sessions attended and the number of self-monitoring records completed
Time Frame
Change from baseline to 16 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariana M. Chao, PhD, CRNP
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Neurocognitive Benefits of a Weight Management Program

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