Healthy Eating, Activity, & Lifestyle Training Headquarters: II (H.E.A.L.T.H -II) Pilot Project
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change from Baseline Weight at 6 Months and 12 Months
Study Overview
Brief 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.
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Waitlist Control Group
Six month delayed access to the H.E.A.L.T.H. II Intervention - Intensive intervention (wait-list control)
Active Intervention Group
Immediate access to the H.E.A.L.T.H. II Intervention - Intensive intervention
Intervention: H.E.A.L.T.H. II Intervention (Behavioral)
Outcomes
Primary Outcomes
Change from Baseline Weight at 6 Months and 12 Months
Time Frame: Baseline, 6 Months, 12 Months
Standard Weight Scale
Secondary Outcomes
No secondary outcomes reported
Investigators
Tiffany Stewart
Associate Professor, Director, Behavior Technology Laboratory
Pennington Biomedical Research Center