Trials / Completed
CompletedNCT02905422
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Pennington Biomedical Research Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2019-04-22
- Completion
- 2019-04-22
- First posted
- 2016-09-19
- Last updated
- 2024-12-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02905422. Inclusion in this directory is not an endorsement.