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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02905422
• Other study ID #: PBRC 2015-013
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Weight Loss

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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Weight at 6 Months and 12 Months	Standard Weight Scale	Baseline, 6 Months, 12 Months