Food, Activity and Behavior Study (FAB)

January 9, 2023 updated by: USDA Grand Forks Human Nutrition Research Center

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in C-reactive protein (CRP)
Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
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
Time Frame: Weeks 0,12, 24
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
Time Frame: Weeks 0,12, 24
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
Time Frame: Weeks 0,12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Food Cognitive Interference
Time Frame: Weeks 0, 12, 24
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
Time Frame: Weeks 0, 12, 24
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
Time Frame: Weeks 0, 12, 24
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
Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
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
Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
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
Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
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
Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
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
Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
The effect of diet and exercise on cholesterol, HDL, triglycerides
Weeks 0, 2, 4, 6, 8, 10, 12, 24
Change in weight control moderators
Time Frame: Weeks 0,12, 24
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
Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
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
Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
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
Time Frame: Weeks 0, 2, 4, 6, 8, 10, 12, 24
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Single nucleotide polymorphisms (SNP)
Time Frame: Weeks 0
Correlation of SNPs associated with skeletal muscle, catecholamine, executive function and food and exercise reinforcement
Weeks 0
micro RNA (miRNA)
Time Frame: Weeks 0, 12, 24
Correlation of miRNAs associated with skeletal muscle, executive function and food and exercise reinforcement
Weeks 0, 12, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
USDA Grand Forks Human Nutrition Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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