Healthy Eating, Activity, & Lifestyle Training Headquarte... | NCT02905422

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

NCT02905422

Sponsor

Pennington Biomedical Research Center

Status

Completed

Last Update Posted

Dec 16, 2024Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Overweight
Weight Loss

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Apr 22, 2019Actual

Completion Date

Apr 22, 2019Actual

First Submitted Date

Sep 7, 2016

First Submission Date that Met QC Criteria

Sep 13, 2016

First Posted Date

Sep 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2024

Last Update Posted Date

Dec 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tiffany Stewart, Associate Professor, Director, Behavior Technology Laboratory, Pennington Biomedical Research CenterPrincipal Investigator

Lead Sponsor

Pennington Biomedical Research CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline Weight at 6 Months and 12 Months	Standard Weight Scale	Baseline, 6 Months, 12 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tiffany Stewart, PhD	Pennington Biomedical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pennington Biomedical Research Center		Baton Rouge	Louisiana	70808	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight
D015431	Weight Loss
D009043	Motor Activity

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided