Food, Activity and Behavior Study (FAB)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity
• Intervention / Treatment: Other: DGA diet WL & exercise; Other: DGA diet WL & no exercise; Other: DGA diet WM & exercise; Other: DGA diet WM & no exercise; Other: Western diet WL & exercise; Other: Western diet WL & no exercise; Other: Western diet WM & exercise; Other: Western diet WM & no exercise

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Grand Forks, North Dakota, United States, 58203
      • USDA Grand Forks Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: DGA diet WL & exercise; Intake of DGA weight loss 8 day rotating menu & PAGA-recommended exercise
Experimental: 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	Other: DGA diet WL & no exercise; Intake of DGA weight loss 8 day rotating menu & no exercise
Experimental: 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	Other: DGA diet WM & exercise; Intake of DGA weight maintenance 8 day rotating menu & PAGA-recommended exercise
Experimental: DGA diet WM & no exercise; Menu to provide DGA-recommended food group amounts at a calorie level to promote weight maintenance with no exercise	Other: DGA diet WM & no exercise; Intake of DGA weight maintenance 8 day rotating menu & no exercise
Experimental: Western diet with WL & exercise; Western-type menu to provide a calorie level to promote weight loss with PAGA-recommended exercise	Other: Western diet WL & exercise; Intake of Western-type weight loss 8 day rotating menu & PAGA-recommended exercise
Experimental: Western diet with WL & no exercise; Western-type menu to provide a calorie level to promote weight loss with no exercise	Other: Western diet WL & no exercise; Intake of Western-type weight loss 8 day rotating menu & no exercise
Experimental: Western diet WM exercise; Western-type menu to provide a calorie level to promote weight maintenance with PAGA-recommended exercise	Other: Western diet WM & exercise; Intake of Western-type weight maintenance 8 day rotating menu & PAGA-recommended exercise
Experimental: Western diet WM no exercise; Western-type menu to provide a calorie level to promote weight maintenance with no exercise	Other: Western diet WM & no exercise; Intake of Western-type weight maintenance 8 day rotating menu & no exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Cognitive Interference	The effect of diet and exercise on food cognitive interference, one of the three cognitive domains of executive function, using a computerized Food Stroop test.	Weeks 0, 12, 24
Cognitive flexibility	The effect of diet and exercise on cognitive flexibility, one of the three cognitive domains of executive function, using a computerized Trail-Making test B/A.	Weeks 0, 12, 24
Working memory	The effect of diet and exercise on cognitive flexibility, one of the three cognitive domains of executive function, using the Wisconsin Card Sorting Task.	Weeks 0, 12, 24
Inflammation	The effect of diet and exercise on plasma pro-inflammatory cytokines (e.g., Il-6, MCP-1, TNF-alpha) and anti-inflammatory cytokines (e.g., IL-10, Soluble TNF receptor I and II)	Weeks 0, 2, 4, 6, 8, 10, 12, 24
Change in adipokines	The effect of diet and exercise on plasma adipokines (e.g., adiponectin, resistin)	Weeks 0, 2, 4, 6, 8, 10, 12, 24
Change in myokines	The effect of diet and exercise on plasma myokines (e.g., BDNF, Myostatin, FGF-21, Irisin)	Weeks 0, 2, 4, 6, 8, 10, 12, 24
Change in bile acids	The effect of diet and exercise on plasma bile acids (i.e., glycocholic acid, glyco-CDCA, glyco-HDCA, hyocholic acid, hyodeoxycholic acid)	Weeks 0, 2, 4, 6, 8, 10, 12, 24
Change in blood lipids	The effect of diet and exercise on cholesterol, HDL, triglycerides	Weeks 0, 2, 4, 6, 8, 10, 12, 24
Change in weight control moderators	Questionnaires (i.e., three-factor eating questionnaire, reward base eating, food attitudes and behavior survey) that when scored provide a single number will be used to determine the moderating effect of self efficacy, restraint and disinhibition maintaining diet and exercise changes	Weeks 0,12, 24
Change in humoral biomarkers of eating behavior	The effect of diet and exercise on ghrelin, leptin, thyroid hormones, gut peptides, fatty acids	Weeks 0, 2, 4, 6, 8, 10, 12, 24
Gene expression profiles of glucose oxidation	The effect of diet and exercise on gene expression profiles associated with glucose oxidation (i.e., hexokinase, phosphofructokinase, pyruvate dehydrogenase kinase 4, peroxisome proliferator-activated receptor alpha gene expression)	Weeks 0, 2, 4, 6, 8, 10, 12, 24
Gene expression profiles of fat oxidation	The effect of diet and exercise on on gene expression profiles associated with fat oxidation (i.e., fatty acid translocase, fatty acid synthase, acetyl Co-A carboxylase 2, stearoyl Co-A desaturase gene expression)	Weeks 0, 2, 4, 6, 8, 10, 12, 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single nucleotide polymorphisms (SNP)	Correlation of SNPs associated with skeletal muscle, catecholamine, executive function and food and exercise reinforcement	Weeks 0
micro RNA (miRNA)	Correlation of miRNAs associated with skeletal muscle, executive function and food and exercise reinforcement	Weeks 0, 12, 24

Collaborators and Investigators

• Sponsor: USDA Grand Forks Human Nutrition Research Center

Publications and helpful links

Helpful Links

• Grand Forks Human Nutrition Research Center Current Nutrition Studies

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2024
• Primary Completion (Anticipated): December 1, 2029
• Study Completion (Anticipated): December 1, 2029

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GFHNRC512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No