Type 2 DiabetesNCT02555631
PowerUp for Health: A Diabetes Prevention Program for Men
A study testing lifestyle in people with Type 2 Diabetes and Men, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The purpose of this two-year proposal is to: 1. develop and 2. complete a pilot test of an adaptation of the evidence-based National Diabetes Prevention Program (NDPP) tailored to engage men with prediabetes in disadvantaged communities in New York City. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Men
- What is being tested?
- lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pre-diabetes by ADA risk test or an A1c in past year in prediabetes range
- BMI 24 or above (22 for Asians)
- male
- lives, works or spend much time in the disadvantaged neighborhood of the park site
Who cannot join
- cannot read or write in English or Spanish
- has diagnosed diabetes
- obvious mental disability so as to preclude health behavior changes
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Translating the Diabetes Prevention Program to Engage Men From Disadvantaged Areas
The purpose of this two-year proposal is to:
- develop and
- complete a pilot test of an adaptation of the evidence-based National Diabetes Prevention Program (NDPP) tailored to engage men with prediabetes in disadvantaged communities in New York City.
The sites for this pilot study are New York City Parks and recreation centers. Study's main outcome is weight loss of 5-7% baseline weight.
Read the detailed description
During year one, the multi-disciplinary research team will work closely with the expert and community Advisory Panel and consultants to adapt the standard NDPP curriculum in order to promote increased engagement of men. "Engagement" is defined in this proposal to include recruitment, group participation and retention in the 16-week program. This modified NDPP♂ (i.e., for men) renamed by the advisory panel as "Power Up for Health," will have only NDPP-trained male coaches and male participants, with adaptations to dietary and physical activity messaging and a new behavioral "toolbox" approach developed for men.
By month 10 of year one, investigators will begin implementation of the 16-week pilot studies of the NDPP♂ at 6 NYC Parks and Recreation Department (REC) sites in disadvantaged communities in three of the NYC boroughs currently offering the standard NDPP programming. Investigators will utilize an iterative and adaptive process during the pilot phase to modify recruitment and retention strategies, as well as the NDPP curriculum and activities. The exploratory aim, as feasible, is to then compare the adapted NDPP♂ pilot data to the standard NDPP mixed-gender groups' available data on recruitment, participation, weight loss, and retention of men from similar NYC neighborhoods. The goal will be pilot study data from 15-20 male participants at each REC pilot site-a recruitment goal of 120 male participants. Working in collaboration with the investigators' consultants and Advisory Panel of community leaders and academic experts in men's health promotion, as well as study partners at the NYC Department of Parks and Recreation, investigators will conduct focused outreach to the target populations.
The Specific Aims for the Pilot Study are:
Aim 1. to collaborate with the expert and community Advisory Panel to complete the adaptation of the NDPP curriculum and the recruitment and retention activities to better engage men with prediabetes from disadvantaged communities of NYC;
Aim 2. to assess preliminary indicators of effectiveness of the NDPP♂ with respect to reductions in body weight; Hypothesis 1: Men engaged in the NDPP♂ will have reductions in body weight at 16 weeks at least equivalent to the NDPP goal of 5-7% of their baseline body weight.
Aim 3. to examine and describe from pilot data the extent to which recruitment, intervention and retention strategies, tailored for men with prediabetes are associated with improved engagement of the target population; Exploratory Hypothesis 3.1: Recruitment of men to NDPP♂ will occur more rapidly and with less intensive strategies than recruitment of men to the standard NDPP in comparable communities.
Exploratory Hypothesis 3.2: Men enrolled in the NDPP♂ will be more engaged in program activities and self-report greater improvements in healthy eating and physical activity compared with men in the standard NDPP.
Exploratory Hypothesis 3.3: Men enrolled in the NDPP♂ will have retention rates that are at least equivalent to men in the standard NDPP.
All comparison data analyses are exploratory and as data are available.
Aim 4. to examine preliminary data to identify demographic, psychosocial, neighborhood, and REC site characteristics associated with differential recruitment, retention and intervention effects in the NDPP♂.
- Conditions
- Type 2 Diabetes, Men
- Being tested
- lifestyle
- Keywords
- type 2 diabetes, prevention, men
- Medical subject headings
- Diabetes Mellitus, Type 2, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyleBehavioural
In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session
| Study group | Role | What they receive |
|---|---|---|
| lifestyle intervention | Experimental | In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session Receives: Behavioral: lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight in Pounds
the goal is to lose 5-7% of baseline body weight for pre-diabetic men
Measured: Baseline, 16 weeks
Secondary outcomes (3)
Number of Men Enrolled During 8 Weeks of Recruitment
measured by numbers of men and the timeframe in which the recruitment takes place;
Measured: 8 weeks
Number of Sessions Attended
with a measured goal of at least attendance observed and recorded at 9/16 sessions on average
Measured: 16 weeks
Number of Participants That Participated in Each Session
this is measured by direct observation at selected sessions; report by the lifestyle coach; and discussion during focus groups at the end of the 16 weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The New York Academy of Medicine, University of Pittsburgh, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Elizabeth Walker, Albert Einstein College of Medicine
- Investigators
- Elizabeth A. Walker, PhD, RN, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555631
- Sponsor's protocol ID
- 2014-3604
- Other IDs
- R18DK102080
- Status last verified
- Jun 2018
- First submitted
- 17 Sep 2015
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating the Diabetes Prevention Program to Engage Men From Disadvantaged Areas
- ClinicalTrials.gov ID
- NCT02555631
- Acronym / sponsor ID
- 2014-3604
- Conditions
- Type 2 Diabetes, Men
- Keywords
- type 2 diabetes, prevention, men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- The New York Academy of Medicine, University of Pittsburgh, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Posted 28 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this two-year proposal is to:
- develop and
- complete a pilot test of an adaptation of the evidence-based National Diabetes Prevention Program (NDPP) tailored to engage men with prediabetes in disadvantaged communities in New York City.
The sites for this pilot study are New York City Parks and recreation centers. Study's main outcome is weight loss of 5-7% baseline weight.
Detailed description
During year one, the multi-disciplinary research team will work closely with the expert and community Advisory Panel and consultants to adapt the standard NDPP curriculum in order to promote increased engagement of men. "Engagement" is defined in this proposal to include recruitment, group participation and retention in the 16-week program. This modified NDPP♂ (i.e., for men) renamed by the advisory panel as "Power Up for Health," will have only NDPP-trained male coaches and male participants, with adaptations to dietary and physical activity messaging and a new behavioral "toolbox" approach developed for men.
By month 10 of year one, investigators will begin implementation of the 16-week pilot studies of the NDPP♂ at 6 NYC Parks and Recreation Department (REC) sites in disadvantaged communities in three of the NYC boroughs currently offering the standard NDPP programming. Investigators will utilize an iterative and adaptive process during the pilot phase to modify recruitment and retention strategies, as well as the NDPP curriculum and activities. The exploratory aim, as feasible, is to then compare the adapted NDPP♂ pilot data to the standard NDPP mixed-gender groups' available data on recruitment, participation, weight loss, and retention of men from similar NYC neighborhoods. The goal will be pilot study data from 15-20 male participants at each REC pilot site-a recruitment goal of 120 male participants. Working in collaboration with the investigators' consultants and Advisory Panel of community leaders and academic experts in men's health promotion, as well as study partners at the NYC Department of Parks and Recreation, investigators will conduct focused outreach to the target populations.
The Specific Aims for the Pilot Study are:
Aim 1. to collaborate with the expert and community Advisory Panel to complete the adaptation of the NDPP curriculum and the recruitment and retention activities to better engage men with prediabetes from disadvantaged communities of NYC;
Aim 2. to assess preliminary indicators of effectiveness of the NDPP♂ with respect to reductions in body weight; Hypothesis 1: Men engaged in the NDPP♂ will have reductions in body weight at 16 weeks at least equivalent to the NDPP goal of 5-7% of their baseline body weight.
Aim 3. to examine and describe from pilot data the extent to which recruitment, intervention and retention strategies, tailored for men with prediabetes are associated with improved engagement of the target population; Exploratory Hypothesis 3.1: Recruitment of men to NDPP♂ will occur more rapidly and with less intensive strategies than recruitment of men to the standard NDPP in comparable communities.
Exploratory Hypothesis 3.2: Men enrolled in the NDPP♂ will be more engaged in program activities and self-report greater improvements in healthy eating and physical activity compared with men in the standard NDPP.
Exploratory Hypothesis 3.3: Men enrolled in the NDPP♂ will have retention rates that are at least equivalent to men in the standard NDPP.
All comparison data analyses are exploratory and as data are available.
Aim 4. to examine preliminary data to identify demographic, psychosocial, neighborhood, and REC site characteristics associated with differential recruitment, retention and intervention effects in the NDPP♂.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle intervention | Experimental | Behavioral: lifestyleIn this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pre-diabetes by ADA risk test or an A1c in past year in prediabetes range
- BMI 24 or above (22 for Asians)
- male
- lives, works or spend much time in the disadvantaged neighborhood of the park site
Key exclusion criteria (3 listed)
- cannot read or write in English or Spanish
- has diagnosed diabetes
- obvious mental disability so as to preclude health behavior changes
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 |
|---|---|---|
| lifestyleIn this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session | Behavioural | lifestyle intervention |
Primary outcome
Change in Weight in Pounds
Time frame: Baseline, 16 weeks
the goal is to lose 5-7% of baseline body weight for pre-diabetic men
3 secondary outcomes
Number of Men Enrolled During 8 Weeks of Recruitment
Time frame: 8 weeks
Number of Sessions Attended
Time frame: 16 weeks
Number of Participants That Participated in Each Session
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elizabeth A. Walker, PhD, RN principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle in people with Type 2 Diabetes and Men, run by Albert Einstein College of Medicine 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 4 inclusion and 3 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 28 Jun 2018. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Weight in Pounds (time frame: Baseline, 16 weeks). 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 28 Jun 2018.