Food, Activity and Behavior Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

DGA diet WL & exercise

Intervention Type OTHER

Intake of DGA weight loss 8 day rotating menu \& PAGA-recommended exercise

DGA diet with WL & no exercise

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

Group Type EXPERIMENTAL

DGA diet WL & no exercise

Intervention Type OTHER

Intake of DGA weight loss 8 day rotating menu \& no exercise

DGA diet weight maintenance (WM) & exercise

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

Group Type EXPERIMENTAL

DGA diet WM & exercise

Intervention Type OTHER

Intake of DGA weight maintenance 8 day rotating menu \& PAGA-recommended exercise

DGA diet WM & no exercise

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

Group Type EXPERIMENTAL

DGA diet WM & no exercise

Intervention Type OTHER

Intake of DGA weight maintenance 8 day rotating menu \& no exercise

Western diet with WL & exercise

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

Group Type EXPERIMENTAL

Western diet WL & exercise

Intervention Type OTHER

Intake of Western-type weight loss 8 day rotating menu \& PAGA-recommended exercise

Western diet with WL & no exercise

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

Group Type EXPERIMENTAL

Western diet WL & no exercise

Intervention Type OTHER

Intake of Western-type weight loss 8 day rotating menu \& no exercise

Western diet WM exercise

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

Group Type EXPERIMENTAL

Western diet WM & exercise

Intervention Type OTHER

Intake of Western-type weight maintenance 8 day rotating menu \& PAGA-recommended exercise

Western diet WM no exercise

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

Group Type EXPERIMENTAL

Western diet WM & no exercise

Intervention Type OTHER

Intake of Western-type weight maintenance 8 day rotating menu \& no exercise

Interventions

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DGA diet WL & exercise

Intake of DGA weight loss 8 day rotating menu \& PAGA-recommended exercise

Intervention Type OTHER

DGA diet WL & no exercise

Intake of DGA weight loss 8 day rotating menu \& no exercise

Intervention Type OTHER

DGA diet WM & exercise

Intake of DGA weight maintenance 8 day rotating menu \& PAGA-recommended exercise

Intervention Type OTHER

DGA diet WM & no exercise

Intake of DGA weight maintenance 8 day rotating menu \& no exercise

Intervention Type OTHER

Western diet WL & exercise

Intake of Western-type weight loss 8 day rotating menu \& PAGA-recommended exercise

Intervention Type OTHER

Western diet WL & no exercise

Intake of Western-type weight loss 8 day rotating menu \& no exercise

Intervention Type OTHER

Western diet WM & exercise

Intake of Western-type weight maintenance 8 day rotating menu \& PAGA-recommended exercise

Intervention Type OTHER

Western diet WM & no exercise

Intake of Western-type weight maintenance 8 day rotating menu \& no exercise

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes