NCT04577547

Food, Activity and Behavior Study

Efficacy of the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans for Weight Control

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: USDA Grand Forks Human Nutrition Research Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Obesity

Interventions

Type	Name	Description
OTHER	DGA diet WL & exercise	Intake of DGA weight loss 8 day rotating menu \& PAGA-recommended exercise
OTHER	DGA diet WL & no exercise	Intake of DGA weight loss 8 day rotating menu \& no exercise
OTHER	DGA diet WM & exercise	Intake of DGA weight maintenance 8 day rotating menu \& PAGA-recommended exercise
OTHER	DGA diet WM & no exercise	Intake of DGA weight maintenance 8 day rotating menu \& no exercise
OTHER	Western diet WL & exercise	Intake of Western-type weight loss 8 day rotating menu \& PAGA-recommended exercise
OTHER	Western diet WL & no exercise	Intake of Western-type weight loss 8 day rotating menu \& no exercise
OTHER	Western diet WM & exercise	Intake of Western-type weight maintenance 8 day rotating menu \& PAGA-recommended exercise
OTHER	Western diet WM & no exercise	Intake of Western-type weight maintenance 8 day rotating menu \& no exercise

Timeline

• Start date: 2024-10-01
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2020-10-08
• Last updated: 2023-01-11