Food, Activity and Behavior Study (FAB)

USDA Grand Forks Human Nutrition Research Center

Status: Withdrawn

Conditions: Obesity

Treatments: Other: DGA diet WM & no exercise; Other: Western diet WL & no exercise; Other: DGA diet WL & no exercise; Other: DGA diet WL & exercise; Other: Western diet WL & exercise; Other: Western diet WM & exercise; Other: Western diet WM & no exercise; Other: DGA diet WM & exercise

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04577547

GFHNRC512

Details and patient eligibility

About

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.

Full description

The Dietary Guidelines for Americans (DGA), which include the Physical Activity Guidelines for Americans (PAGA), is the primary United States (U.S) government resource for weight control. The researchers propose that chronic, low grade inflammation (CLGI) limits weight control by acting upon physiological and behavioral factors that moderate weight control. Diet and exercise reduce CLGI and provide weight control, but no one has investigated the efficacy of the DGA and PAGA to reduce CLGI, whether reduced CLGI promotes greater weight control, and the moderating roles of physiological and behavioral factors on the association of reduced CLGI with weight control. To accomplish this, the researchers will conduct a 6-month trial in 224 obese adults; a 3-month controlled feeding trial with four dietary arms; 1) DGA with weight loss, 2) Western diet with weight loss,3) DGA diet weight maintenance, 4) Western diet weight maintenance. Each dietary arm will have PAGA-recommended exercise and non-exercise arms. Post-trial is a 3-month weight maintenance period. The primary outcome is change in C-reactive protein (CRP), a marker of CLGI. The results will inform the DGA and PAGA; thereby helping clinicians, public health workers, and policymakers to improve the health of Americans.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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0 participants in 8 patient groups

Dietary Guidelines (DGA) diet with weight loss (WL) & exercise

Experimental group

Description:

Menu to provide DGA-recommended food group amounts at a calorie level to promote weight loss with Physical Activity Guidelines for Americans (PAGA)-recommended exercise

Treatment:

Other: DGA diet WL & exercise

DGA diet with WL & no exercise

Experimental group

Description:

Menu to provide DGA-recommended food group amounts at a calorie level to promote weight loss with no exercise

Treatment:

Other: DGA diet WL & no exercise

DGA diet weight maintenance (WM) & exercise

Experimental group

Description:

Menu to provide DGA-recommended food group amounts at a calorie level to promote weight maintenance with PAGA-recommended exercise

Treatment:

Other: DGA diet WM & exercise

DGA diet WM & no exercise

Experimental group

Description:

Menu to provide DGA-recommended food group amounts at a calorie level to promote weight maintenance with no exercise

Treatment:

Other: DGA diet WM & no exercise

Western diet with WL & exercise

Experimental group

Description:

Western-type menu to provide a calorie level to promote weight loss with PAGA-recommended exercise

Treatment:

Other: Western diet WL & exercise

Western diet with WL & no exercise

Experimental group

Description:

Western-type menu to provide a calorie level to promote weight loss with no exercise

Treatment:

Other: Western diet WL & no exercise

Western diet WM exercise

Experimental group

Description:

Western-type menu to provide a calorie level to promote weight maintenance with PAGA-recommended exercise

Treatment:

Other: Western diet WM & exercise

Western diet WM no exercise

Experimental group

Description:

Western-type menu to provide a calorie level to promote weight maintenance with no exercise

Treatment:

Other: Western diet WM & no exercise