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Food, Activity and Behavior Study
FAB
Efficacy of the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans for Weight Control
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this research is to test the effects of the Dietary and Physical Activity Guidelines for Americans on health and on eating and exercise behaviors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2024
Longer than P75 for not_applicable obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
January 11, 2023
January 1, 2023
5.2 years
June 18, 2020
January 9, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Change in C-reactive protein (CRP)
The effect of diet and exercise on CRP
Weeks 0, 2, 4, 6, 8, 10, 12, 24
Relative reinforcing value (RRV) of energy-dense snack foods
The effect of consuming a healthy DGA style or a Western style diet during weight loss and weight maintenance on the RRV of energy-dense snack food using a computer choice paradigm. For the computer choice paradigm subjects click the mouse button to play a simulated slot machine games to earn points toward receiving a portion of food or being able to do a non-food related sedentary activity (e.g., watching TV).
Weeks 0,12, 24
Relative reinforcing value (RRV) of exercise
The effect of achieving the DGA recommended amounts of exercise during weight loss and weight maintenance on relative reinforcing value of exercise compared to a sedentary activity alternative using a computer choice paradigm. For the computer choice paradigm subjects click the mouse button to play a simulated slot machine games to earn points toward being able to do a chosen physical activity, such as walking on a treadmill, or a sedentary activity (e.g., watching TV).
Weeks 0,12, 24
Fat and carbohydrate oxidation
The effect of diet and exercise on carbohydrate and fat oxidation in response to meals and exercise as measured by whole-room calorimetry
Weeks 0,12
Secondary Outcomes (12)
Food Cognitive Interference
Weeks 0, 12, 24
Cognitive flexibility
Weeks 0, 12, 24
Working memory
Weeks 0, 12, 24
Inflammation
Weeks 0, 2, 4, 6, 8, 10, 12, 24
Change in adipokines
Weeks 0, 2, 4, 6, 8, 10, 12, 24
- +7 more secondary outcomes
Other Outcomes (2)
Single nucleotide polymorphisms (SNP)
Weeks 0
micro RNA (miRNA)
Weeks 0, 12, 24
Study Arms (8)
Dietary Guidelines (DGA) diet with weight loss (WL) & exercise
EXPERIMENTALMenu to provide DGA-recommended food group amounts at a calorie level to promote weight loss with Physical Activity Guidelines for Americans (PAGA)-recommended exercise
DGA diet with WL & no exercise
EXPERIMENTALMenu to provide DGA-recommended food group amounts at a calorie level to promote weight loss with no exercise
DGA diet weight maintenance (WM) & exercise
EXPERIMENTALMenu to provide DGA-recommended food group amounts at a calorie level to promote weight maintenance with PAGA-recommended exercise
DGA diet WM & no exercise
EXPERIMENTALMenu to provide DGA-recommended food group amounts at a calorie level to promote weight maintenance with no exercise
Western diet with WL & exercise
EXPERIMENTALWestern-type menu to provide a calorie level to promote weight loss with PAGA-recommended exercise
Western diet with WL & no exercise
EXPERIMENTALWestern-type menu to provide a calorie level to promote weight loss with no exercise
Western diet WM exercise
EXPERIMENTALWestern-type menu to provide a calorie level to promote weight maintenance with PAGA-recommended exercise
Western diet WM no exercise
EXPERIMENTALWestern-type menu to provide a calorie level to promote weight maintenance with no exercise
Interventions
Intake of DGA weight loss 8 day rotating menu \& PAGA-recommended exercise
Intake of DGA weight loss 8 day rotating menu \& no exercise
Intake of DGA weight maintenance 8 day rotating menu \& PAGA-recommended exercise
Intake of DGA weight maintenance 8 day rotating menu \& no exercise
Intake of Western-type weight loss 8 day rotating menu \& PAGA-recommended exercise
Intake of Western-type weight loss 8 day rotating menu \& no exercise
Intake of Western-type weight maintenance 8 day rotating menu \& PAGA-recommended exercise
Intake of Western-type weight maintenance 8 day rotating menu \& no exercise
Eligibility Criteria
You may qualify if:
- Obese (BMI 30.0 kg/m2 - 350 lbs \[maximum weight for dual energy x-ray absorptiometry (DXA) machine\])
- No contraindications to participate in exercise
- hs-CRP level ≥3.0 and ≤10.0 mg/L or two consecutive measures of \>10.0 mg/L measured two weeks apart
- Access to high-speed internet
You may not qualify if:
- Taking chronic anti-inflammatory medications
- Being pregnant, lactating, or planning to become pregnant
- Diagnosed eating disorder
- Taking weight loss medication
- Smoking
- Overt hypothyroidism
- Cancer
- Physical conditions that prevent safe exercise
- Liking of \<3 out of 10 for all available physical activity modes
- Currently exercising for more than 30 minutes per day \>3 days per week
- Unwilling to continue with current exercise routine
- Not willing to comply with all study requirements
- Blood pressure greater than 140/90
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shanon Casperson, PhD
USDA Grand Forks Human Nutrition Research Center
- PRINCIPAL INVESTIGATOR
James Roemmich, PhD
USDA Grand Forks Human Nutrition Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
October 8, 2020
Study Start
October 1, 2024
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
January 11, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share