OverweightNCT02905422
Healthy Eating, Activity, & Lifestyle Training Headquarters: II Pilot Project
A study testing H.E.A.L.T.H. II Intervention in people with Overweight and Weight Loss, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Weight Loss
- What is being tested?
- H.E.A.L.T.H. II Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 22 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Healthy Eating, Activity, & Lifestyle Training Headquarters: II (H.E.A.L.T.H -II) Pilot Project
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.
Read the 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.
- Conditions
- Overweight, Weight Loss
- Being tested
- H.E.A.L.T.H. II Intervention
- Keywords
- physical activity, sleep, nutrition, Soldier, prevention, remote monitoring, mobile technology
- Medical subject headings
- Overweight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.E.A.L.T.H. II InterventionBehavioural
Also called Army H.E.A.L.T.H. Intensive
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: H.E.A.L.T.H. II Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Weight at 6 Months and 12 Months
Standard Weight Scale
Measured: Baseline, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startJan 2016
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiffany Stewart, Pennington Biomedical Research Center
- Investigators
- Tiffany Stewart, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905422
- Sponsor's protocol ID
- PBRC 2015-013
- Status last verified
- Dec 2024
- First submitted
- 7 Sep 2016
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating, Activity, & Lifestyle Training Headquarters: II (H.E.A.L.T.H -II) Pilot Project
- ClinicalTrials.gov ID
- NCT02905422
- Acronym / sponsor ID
- PBRC 2015-013
- Conditions
- Overweight, Weight Loss
- Keywords
- physical activity, sleep, nutrition, Soldier, prevention, remote monitoring, mobile technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: H.E.A.L.T.H. II InterventionImmediate access to the H.E.A.L.T.H. II Intervention - Intensive intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and Female Soldiers who are members of the Louisiana National Guard
- ≥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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H.E.A.L.T.H. II InterventionAlso: Army H.E.A.L.T.H. Intensive12 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. | Behavioural | Active Intervention Group |
Primary outcome
Change from Baseline Weight at 6 Months and 12 Months
Time frame: Baseline, 6 Months, 12 Months
Standard Weight Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany Stewart, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H.E.A.L.T.H. II Intervention in people with Overweight and Weight Loss, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Weight at 6 Months and 12 Months (time frame: Baseline, 6 Months, 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.