Healthy Eating, Activity, & Lifestyle Training Headquarters: II Pilot Project
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|ClinicalTrials.gov Identifier: NCT02905422|
Recruitment Status : Active, not recruiting
First Posted : September 19, 2016
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Overweight Weight Loss||Behavioral: H.E.A.L.T.H. II Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Healthy Eating, Activity, & Lifestyle Training Headquarters: II (H.E.A.L.T.H -II) Pilot Project|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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 Name: Army H.E.A.L.T.H. Intensive
- Change from Baseline Weight at 6 Months and 12 Months [ Time Frame: Baseline, 6 Months, 12 Months ]Standard Weight Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905422
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Tiffany Stewart, PhD||Pennington Biomedical Research Center|