Healthy Eating, Activity, & Lifestyle Training Headquarters: II Pilot Project

The proposed study aims to combine evidenced based tools and guidance (H.E.A.L.T.H.: Healthy Eating Activity Lifestyle Training Headquarters) previously tested that has been developed specifically for use by Army Soldiers and a remote clinical intervention model that includes mobile tracking technology/devices for physical activity, weight and nutrition. This program is called the H.E.A.L.T.H. Intensive.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

The purpose of this investigation is to test the efficacy of a remote intervention to assist Soldiers in meeting standards for body fat and fitness. The intervention will include:

An Internet/Smartphone program for weight management and weight gain prevention developed during previous DoD research.
Integrated remote monitoring technology/devices, e.g. smart scales, activity tracking devices.
Individualized weight management and exercise recommendations based on data collected from web/mobile app/devices to be delivered via web/mobile app/Smartphone; participants will not travel to a clinical facility for the intervention.

The objectives are:

to further develop the H.E.A.L.T.H. intervention by merging components of the H.E.A.L.T.H. program, remote monitoring technology components, e.g. activity tracking devices, smart scales, and direct/individualized weight management and exercise feedback into a single and comprehensive intervention that targets weight and fat loss, improved fitness, improved sleep, and personal well-being for Soldiers and their family members.
Compare body weight, body fat, and activity changes associated with participation in the H.E.A.L.T.H Intensive intervention for six months and a six-month website only phase/follow-up phase, in comparison to participation in a wait-list control group; and
Evaluate blood biomarkers associated with changes in body weight. Evaluate changes in gut bacteria associated with body weight.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and Female Soldiers who are members of the Louisiana National Guard

Direct family member of the LANG member who is enrolled in the study and will participate with the Soldier
≥18 years old
For Soldiers: BMI ≥ 25, AND who exceeds Screening Table Weight AND maximum allowed body fat as outlined by AR600-9 Army regulations For Family Member: BMI ≥ 25
Has no known deployments (to the best of their knowledge) for one year upon beginning the study

Exclusion criteria

Soldiers and family members younger than 18 years of age
Soldiers and family members who are pregnant
Soldiers and family members who cannot read
Soldiers and family members who do not have daily access to wifi
Soldiers and family members who do not have access to a smartphone

Treatment and study plan

H.E.A.L.T.H. II Intervention

Behavioral

12 month study with 6 month intervention phase and 6 month follow up phase. Participants will receive bi-weekly educational information pertaining to weight loss during the intervention phase. Participants will use online website to monitor weight, access meal plans, access weight loss information, and access fitness plans.

Other names: Army H.E.A.L.T.H. Intensive

Primary outcomes

Change from Baseline Weight at 6 Months and 12 Months

Time frame: Baseline, 6 Months, 12 Months

Standard Weight Scale

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Healthy Eating, Activity, & Lifestyle Training Headquarters: II (H.E.A.L.T.H -II) Pilot Project

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Sep 19, 2016
Registry last updated: Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed