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| Name | Class |
|---|---|
| WW International Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WW (formerly Weight Watchers) | Experimental | 16-weeks of the group-based WW program |
|
| Waitlist Control | Other | 16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WW (formerly Weight Watchers) | Behavioral | The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex | Changes in BOLD fMRI response to high-calorie food images | Change from baseline to 16 weeks |
| 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 |
| Food Cravings- Trait (Lack of Control Over Eating) | Changes in scores on the Food Cravings Questionnaire- Trait (lack of control over eating), range=6-36, higher scores indicate greater cravings | Change from baseline to 16 weeks |
| Food Preference | Changes in scores on the Leeds Food Preference Questionnaire | Change from baseline to 16 weeks |
| Eating Behaviors | 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 | Change from baseline to 16 weeks |
| Hippocampal Volume | Change in hippocampal volume | Change from baseline to 16 weeks |
| BOLD fMRI Response to the N-back Task | Changes in BOLD fMRI response to the N-back task |
| Measure | Description | Time Frame |
|---|---|---|
| N-back Behavioral Performance | Change in reaction time (seconds) on the N-back task | Change from baseline to 16 weeks |
| Percent Weight | Percent weight change |
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Inclusion Criteria:
Ages 18-60 years
Female
BMI>30 kg/m2
Eligible female patients will be:
Participants must:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Ariana M. Chao, PhD, CRNP | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37916843 | Derived | Chao AM, Wadden TA, Cao W, Zhou Y, Maldonado D, Cardel MI, Foster GD, Loughead J. Randomized Controlled Trial of Effects of Behavioral Weight Loss Treatment on Food Cue Reactivity. Nurs Res. 2024 Mar-Apr 01;73(2):91-100. doi: 10.1097/NNR.0000000000000702. Epub 2023 Oct 31. | |
| 37156318 | Derived | Chao AM, Zhou Y, Erus G, Davatzikos C, Cardel MI, Foster GD, Wadden TA. A randomized controlled trial examining the effects of behavioral weight loss treatment on hippocampal volume and neurocognition. Physiol Behav. 2023 Aug 1;267:114228. doi: 10.1016/j.physbeh.2023.114228. Epub 2023 May 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | WW (Formerly Weight Watchers) | 16-weeks of the group-based WW program WW (formerly Weight Watchers): The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides. |
| FG001 | Waitlist Control | 16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program Waitlist: The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | WW (Formerly Weight Watchers) | 16-weeks of the group-based WW program WW (formerly Weight Watchers): The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides. |
| BG001 | Waitlist Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex | Changes in BOLD fMRI response to high-calorie food images | Posted | Mean | Standard Error | percent BOLD signal change | Change from baseline to 16 weeks |
|
Baseline and follow-up (16 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WW (Formerly Weight Watchers) | 16-weeks of the group-based WW program WW (formerly Weight Watchers): The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ariana Chao | University of Pennsylvanai | 215-746-7183 | arichao@upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 6, 2020 | Jan 17, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2024 | Jul 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Waitlist | Behavioral | The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention |
|
| Change from baseline to 16 weeks |
| Eating Behaviors (Low-calorie Foods) | 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 | Change from baseline to 16 weeks |
| Change from baseline to 16 weeks |
| 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). 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. | Change from baseline to 16 weeks |
| Power of Food | Changes in eating behavior as measured by the Power of Food Scale; higher scores indicate greater hedonic hunger. Range of scores is 1-5 | Change from baseline to 16 weeks |
16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program
Waitlist: The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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 | Posted | Mean | Standard Error | units on a scale | Change from baseline to 16 weeks |
|
|
|
| Primary | Food Cravings- Trait (Lack of Control Over Eating) | Changes in scores on the Food Cravings Questionnaire- Trait (lack of control over eating), range=6-36, higher scores indicate greater cravings | Posted | Mean | Standard Error | score on a scale | Change from baseline to 16 weeks |
|
|
|
| Primary | Food Preference | Changes in scores on the Leeds Food Preference Questionnaire | Data not analyzed due to technical error with coding of the task that resulted in the data being unusable | Posted | Change from baseline to 16 weeks |
|
|
| Primary | Eating Behaviors | 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 | Posted | Mean | Standard Error | units on a scale | Change from baseline to 16 weeks |
|
|
|
| Primary | Hippocampal Volume | Change in hippocampal volume | Posted | Mean | Standard Error | mm^3 | 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 | Data not analyzed due to technical error due to coding in N-bask task in E-Prime that resulted in the data being unusable | Posted | Change from baseline to 16 weeks |
|
|
| Primary | Eating Behaviors (Low-calorie Foods) | 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 | Posted | Mean | Standard Error | units on a scale | Change from baseline to 16 weeks |
|
|
|
| Secondary | N-back Behavioral Performance | Change in reaction time (seconds) on the N-back task | Data not analyzed due to technical error due to coding in N-bask task in E-Prime that resulted in the data being unusable | Posted | Change from baseline to 16 weeks |
|
|
| Secondary | Percent Weight | Percent weight change | Posted | Mean | Standard Error | percentage of initial weight loss | 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). 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. | Intention to treat | Posted | Mean | Standard Error | score on a scale | 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. Range of scores is 1-5 | Intention to treat | Posted | Mean | Standard Error | score on a scale | Change from baseline to 16 weeks |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Waitlist Control | 16-weeks on waitlist then participants will be provided with 16-weeks of the group-based WW program Waitlist: The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention | 0 | 30 | 0 | 30 | 0 | 30 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Disinhibition |
|