Clinical trial NCT02905422: Healthy Eating, Activity, & Lifestyle Training Headquarters: II Pilot Project
Official title: Healthy Eating, Activity, & Lifestyle Training Headquarters: II (H.E.A.L.T.H -II) Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Weight Loss
Keywords: physical activity
sleep
nutrition
Soldier
prevention
remote monitoring
mobile technology
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Weight at 6 Months and 12 Months
timeFrame: Baseline, 6 Months, 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Tiffany Stewart, PhD
role: PRINCIPAL_INVESTIGATOR
References: