Neurocognitive Benefits of a Weight Management Program

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04202133
• Other study ID #: 834404
• Status: Completed
• Phase: Phase 4
• Start date: November 20, 2019
• Est. completion date: July 20, 2021

Study information

• Verified date: July 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 20, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• WW (formerly Weight Watchers)
The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.
• Waitlist
The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Weight Watchers International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood oxygen level-dependent (BOLD) response to food cues	Changes in BOLD fMRI response to high- and low-calorie food images	Change from baseline to 16 weeks
Primary	Reward-based eating	Changes in scores on the Reward-Based Eating Drive Scale; range of 0-52; higher scores indicate higher reward-related eating	Change from baseline to 16 weeks
Primary	Food cravings	Changes in scores on the Food Cravings Questionnaire; summed scores for subscales; higher scores indicate greater cravings	Change from baseline to 16 weeks
Primary	Food preference	Changes in scores on the Leeds Food Preference Questionnaire	Change from baseline to 16 weeks
Primary	Eating behaviors	Changes in scores on the Eating Behaviors Questionnaire; visual analog scores	Change from baseline to 16 weeks
Primary	Hippocampal volume	Change in hippocampal volume	Change from baseline to 16 weeks
Primary	BOLD fMRI response to the N-back task	Changes in BOLD fMRI response to the N-back task	Change from baseline to 16 weeks
Secondary	N-back behavioral performance	Change in reaction time (seconds) on the N-back task	Change from baseline to 16 weeks
Secondary	Accuracy on N-back Task	Accuracy (percent of correct responses) on the N-back task	Change from baseline to 16 weeks
Secondary	Percent Weight	Percent weight change	Change from baseline to 16 weeks
Secondary	Blood Pressure	Change in systolic and diastolic blood pressure	Change from baseline to 16 weeks
Secondary	Waist Circumference	Change in waist circumference	Change from baseline to 16 weeks
Secondary	Executive Functioning	Changes in executive functioning as measured by the National Institutes of Health Toolbox-Cognitive Function Battery	Change from baseline to 16 weeks
Secondary	Mood	Changes in mood as measured by the Beck Depression Inventory-II; range 0-63; higher scores indicate greater depressive symptoms	Change from baseline to 16 weeks
Secondary	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)	Change from baseline to 16 weeks
Secondary	Binge eating and weight control behaviors	Changes in eating behavior as measured by the Questionnaire on Weight and Eating Pattern-5	Change from baseline to 16 weeks
Secondary	Power of Food	Changes in eating behavior as measured by the Power of Food Scale; higher scores indicate greater hedonic hunger	Change from baseline to 16 weeks
Secondary	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	Change from baseline to 16 weeks
Secondary	Portion sizes	Changes in eating behavior as measured by the Modified Eating Patterns Questionnaire; higher scores indicate higher thresholds for perceived portions	Change from baseline to 16 weeks
Secondary	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)	Change from baseline to 16 weeks
Secondary	Stress	Changes in stress as measured by the Perceived Stress Scale; range of 0-40 with higher scores indicating more stress	Change from baseline to 16 weeks
Secondary	Perceived Nutrition Environment	Changes in perceived nutrition environment as measured by the Perceived Nutrition Environment	Change from baseline to 16 weeks
Secondary	Resilience	Changes in resilience as measured by the Brief Resilience Scale; range of 6-30; greater scores indicate more resilience	Change from baseline to 16 weeks
Secondary	Food Addiction	Changes in food addiction as measured by the Yale Food Addiction Scale 2.0; greater scores indicate greater food addiction symptoms	Change from baseline to 16 weeks
Secondary	Physical Activity	Changes in physical activity as measured by the Paffenbarger Physical Activity Questionnaire	Change from baseline to 16 weeks
Secondary	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	Change from baseline to 16 weeks
Secondary	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)	Change from baseline to 16 weeks
Secondary	Self-regulation	Changes in self-regulation as measured by the Index of Self-Regulation; higher scores indicate greater self-regulation	Change from baseline to 16 weeks
Secondary	Inhibition	Changes in inhibition as measured by the Behavioral Avoidance/Inhibition Scales; drive, fun seeking, reward responsiveness, inhibition; higher scores	Change from baseline to 16 weeks
Secondary	Adherence	Changes in adherence as measured by the number of sessions attended and the number of self-monitoring records completed	Change from baseline to 16 weeks