Healthy Eating, Activity, & Lifestyle Training Headquarters: II Pilot Project
Primary Purpose
Overweight, Weight Loss
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
H.E.A.L.T.H. II Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring physical activity, sleep, nutrition, Soldier, prevention, remote monitoring, mobile technology
Eligibility Criteria
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
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Waitlist Control Group
Active Intervention Group
Arm Description
Six month delayed access to the H.E.A.L.T.H. II Intervention - Intensive intervention (wait-list control)
Immediate access to the H.E.A.L.T.H. II Intervention - Intensive intervention
Outcomes
Primary Outcome Measures
Change from Baseline Weight at 6 Months and 12 Months
Standard Weight Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02905422
First Posted
September 7, 2016
Last Updated
January 12, 2023
Sponsor
Pennington Biomedical Research Center
1. Study Identification
Unique Protocol Identification Number
NCT02905422
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Weight Loss
Keywords
physical activity, sleep, nutrition, Soldier, prevention, remote monitoring, mobile technology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
Six month delayed access to the H.E.A.L.T.H. II Intervention - Intensive intervention (wait-list control)
Arm Title
Active Intervention Group
Arm Type
Active Comparator
Arm Description
Immediate access to the H.E.A.L.T.H. II Intervention - Intensive intervention
Intervention Type
Behavioral
Intervention Name(s)
H.E.A.L.T.H. II Intervention
Other Intervention Name(s)
Army H.E.A.L.T.H. Intensive
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Weight at 6 Months and 12 Months
Description
Standard Weight Scale
Time Frame
Baseline, 6 Months, 12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany Stewart, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Healthy Eating, Activity, & Lifestyle Training Headquarters: II Pilot Project
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