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

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

Study Overview

• Status: Completed
• Conditions: Overweight; Weight Loss
• Intervention / Treatment: Behavioral: H.E.A.L.T.H. II Intervention

Detailed Description

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:

1. An Internet/Smartphone program for weight management and weight gain prevention developed during previous DoD research.
2. Integrated remote monitoring technology/devices, e.g. smart scales, activity tracking devices.
3. 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:

1. 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.
2. 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
3. Evaluate blood biomarkers associated with changes in body weight. Evaluate changes in gut bacteria associated with body weight.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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
2. ≥18 years old
3. 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
4. Has no known deployments (to the best of their knowledge) for one year upon beginning the study

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control Group; Six month delayed access to the H.E.A.L.T.H. II Intervention - Intensive intervention (wait-list control)
Active Comparator: Active Intervention Group; Immediate access to the H.E.A.L.T.H. II Intervention - Intensive intervention	Behavioral: H.E.A.L.T.H. II Intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Weight at 6 Months and 12 Months	Standard Weight Scale	Baseline, 6 Months, 12 Months

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Tiffany Stewart, PhD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): April 22, 2019
• Study Completion (Actual): April 22, 2019

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimated): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; sleep; nutrition; prevention; mobile technology; remote monitoring; Soldier
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Weight Loss
• Other Study ID Numbers: PBRC 2015-013

Plan for Individual participant data (IPD)

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