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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
Sponsor:
Information provided by (Responsible Party):
Tiffany Stewart, Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment Phase
Overweight Weight Loss Behavioral: H.E.A.L.T.H. II Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from Baseline Weight at 6 Months and 12 Months [ Time Frame: Baseline, 6 Months, 12 Months ]
    Standard Weight Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Tiffany Stewart, PhD Pennington Biomedical Research Center

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Responsible Party: Tiffany Stewart, Associate Professor, Director, Behavior Technology Laboratory, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02905422     History of Changes
Other Study ID Numbers: 00006218
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tiffany Stewart, Pennington Biomedical Research Center:
physical activity
sleep
nutrition
Soldier
prevention
remote monitoring
mobile technology

Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes