Healthy Eating, Activity, & Lifestyle Training Headquarters: II Pilot Project

NCT02905422 | Completed

• 1 other identifier: PBRC 2015-013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Weight Loss

Keywords

physical activity; sleep; nutrition; Soldier; prevention; remote monitoring; mobile technology

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Weight at 6 Months and 12 Months

  Standard Weight Scale

  Baseline, 6 Months, 12 Months

Study Arms (2)

Waitlist Control Group

NO INTERVENTION

Six month delayed access to the H.E.A.L.T.H. II Intervention - Intensive intervention (wait-list control)

Active Intervention Group

ACTIVE COMPARATOR

Immediate access to the H.E.A.L.T.H. II Intervention - Intensive intervention

Behavioral: H.E.A.L.T.H. II Intervention

Interventions

H.E.A.L.T.H. II Intervention BEHAVIORAL

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.

Also known as: Army H.E.A.L.T.H. Intensive

Active Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Overweight; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Tiffany Stewart, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director, Behavior Technology Laboratory

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 19, 2016
• Study Start: January 1, 2016
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)