Trial Outcomes & Findings for Neurocognitive Benefits of a Weight Management Program (NCT NCT04202133)
NCT ID: NCT04202133
Last Updated: 2025-02-10
Results Overview
Changes in BOLD fMRI response to high-calorie food images
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
Change from baseline to 16 weeks
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
30
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurocognitive Benefits of a Weight Management Program
Baseline characteristics by cohort
| Measure |
WW (Formerly Weight Watchers)
n=31 Participants
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.
|
Waitlist Control
n=30 Participants
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
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
40.1 years
STANDARD_DEVIATION 11.1 • n=107 Participants
|
41.1 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksChanges in BOLD fMRI response to high-calorie food images
Outcome measures
| Measure |
WW (Formerly Weight Watchers)
n=29 Participants
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.
|
Waitlist Control
n=22 Participants
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
|
|---|---|---|
|
Blood Oxygen Level-dependent (BOLD) Response to High-calorie Foods Cues Minus Neutral Objects in Left Anterior Cingulate Cortex
|
-0.05 percent BOLD signal change
Standard Error 0.05
|
-0.16 percent BOLD signal change
Standard Error 0.06
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksChanges in scores on the Reward-Based Eating Drive Scale; range of 0-52; higher scores indicate higher reward-related eating
Outcome measures
| Measure |
WW (Formerly Weight Watchers)
n=30 Participants
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.
|
Waitlist Control
n=26 Participants
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
|
|---|---|---|
|
Reward-based Eating
|
-3.9 units on a scale
Standard Error 1.4
|
-0.7 units on a scale
Standard Error 1.5
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksChanges in scores on the Food Cravings Questionnaire- Trait (lack of control over eating), range=6-36, higher scores indicate greater cravings
Outcome measures
| Measure |
WW (Formerly Weight Watchers)
n=31 Participants
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.
|
Waitlist Control
n=30 Participants
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
|
|---|---|---|
|
Food Cravings- Trait (Lack of Control Over Eating)
|
-2.7 score on a scale
Standard Error 0.8
|
-0.1 score on a scale
Standard Error 0.9
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksPopulation: Data not analyzed due to technical error with coding of the task that resulted in the data being unusable
Changes in scores on the Leeds Food Preference Questionnaire
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksChanges 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
Outcome measures
| Measure |
WW (Formerly Weight Watchers)
n=31 Participants
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.
|
Waitlist Control
n=30 Participants
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
|
|---|---|---|
|
Eating Behaviors
|
-3.2 units on a scale
Standard Error 2.1
|
1.0 units on a scale
Standard Error 2.3
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksChange in hippocampal volume
Outcome measures
| Measure |
WW (Formerly Weight Watchers)
n=29 Participants
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.
|
Waitlist Control
n=22 Participants
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
|
|---|---|---|
|
Hippocampal Volume
|
-84.9 mm^3
Standard Error 154.8
|
42.8 mm^3
Standard Error 172.9
|
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksPopulation: Data not analyzed due to technical error due to coding in N-bask task in E-Prime that resulted in the data being unusable
Changes in BOLD fMRI response to the N-back task
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Change from baseline to 16 weeksChanges 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
Outcome measures
| Measure |
WW (Formerly Weight Watchers)
n=31 Participants
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.
|
Waitlist Control
n=30 Participants
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
|
|---|---|---|
|
Eating Behaviors (Low-calorie Foods)
|
0.7 units on a scale
Standard Error 2.3
|
-0.8 units on a scale
Standard Error 2.3
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeksPopulation: Data not analyzed due to technical error due to coding in N-bask task in E-Prime that resulted in the data being unusable
Change in reaction time (seconds) on the N-back task
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline to 16 weeksPercent weight change
Outcome measures
| Measure |
WW (Formerly Weight Watchers)
n=31 Participants
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.
|
Waitlist Control
n=30 Participants
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
|
|---|---|---|
|
Percent Weight
|
-4.7 percentage of initial weight loss
Standard Error 4.9
|
0.2 percentage of initial weight loss
Standard Error 3.5
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeksPopulation: Intention to treat
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.
Outcome measures
| Measure |
WW (Formerly Weight Watchers)
n=30 Participants
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.
|
Waitlist Control
n=26 Participants
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
|
|---|---|---|
|
Eating Behavior
Hunger
|
-0.9 score on a scale
Standard Error 0.4
|
-0.7 score on a scale
Standard Error 0.5
|
|
Eating Behavior
Disinhibition
|
-1.5 score on a scale
Standard Error 0.4
|
-0.4 score on a scale
Standard Error 0.5
|
|
Eating Behavior
Cognitive restraint
|
3.5 score on a scale
Standard Error 0.6
|
0.3 score on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Change from baseline to 16 weeksPopulation: Intention to treat
Changes in eating behavior as measured by the Power of Food Scale; higher scores indicate greater hedonic hunger. Range of scores is 1-5
Outcome measures
| Measure |
WW (Formerly Weight Watchers)
n=30 Participants
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.
|
Waitlist Control
n=26 Participants
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
|
|---|---|---|
|
Power of Food
|
-0.4 score on a scale
Standard Error 0.6
|
-0.1 score on a scale
Standard Error 0.7
|
Adverse Events
WW (Formerly Weight Watchers)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place