Diabetes Mellitus, Type 2NCT02700503
Finding the Patient's Voice Diabetes Prevention Programs
A study testing Encourage 2.0 in people with Diabetes Mellitus, Type 2 and Prediabetic State, run by Indiana University at 3 sites in United States.
Trial summary
This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Prediabetic State
- What is being tested?
- Encourage 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2015to Jun 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height)
- At least two of the following risk factors:
- Have been diagnosed with prediabetes;
- Have a family history of T2DM in first- and second-degree relatives;
- Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);
- Have conditions associated with insulin resistance; and/or
- Have had gestational diabetes or were exposed to gestational diabetes in utero.
- A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).
Who cannot join
- 1. Type 2 diagnosis
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Riley Children's Specialties
Carmel, Indiana, 46032
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Riley Children's Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs
This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.
Read the detailed description
Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including:
- helping youth/families understand the importance of prevention,
- on-going interest and participation, and
- differing personal beliefs.
Patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.
- Conditions
- Diabetes Mellitus, Type 2, Prediabetic State
- Being tested
- Encourage 2.0
- Keywords
- Diabetes prevention, type 2 diabetes, prediabetes, family
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encourage 2.0Behavioural
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied. Receives: Behavioral: Encourage 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
Measured: 12 months
Secondary outcomes (5)
Hemoglobin A1C
Measured: 12 months
Physical activity
self-report
Measured: 12 months
Quality of life
Pediatric Quality of Life Inventory
Measured: 12 months
Intervention group session attendance
Measured: 12 months
Dietary records
Semi-quantitative food frequency questionniare
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health
- Responsible party
- Principal investigator, Tamara S. Hannon, Indiana University
- Investigators
- Tamara Hannon, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700503
- Sponsor's protocol ID
- 1510313617
- Status last verified
- Aug 2019
- First submitted
- 23 Feb 2016
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs
- ClinicalTrials.gov ID
- NCT02700503
- Acronym / sponsor ID
- 1510313617
- Conditions
- Diabetes Mellitus, Type 2, Prediabetic State
- Keywords
- Diabetes prevention, type 2 diabetes, prediabetes, family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 7 Mar 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.
This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.
Detailed description
Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including:
- helping youth/families understand the importance of prevention,
- on-going interest and participation, and
- differing personal beliefs.
Patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Encourage 2.0Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height)
- At least two of the following risk factors:
- A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).
Key exclusion criteria (1 listed)
- 1. Type 2 diagnosis
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 |
|---|---|---|
| Encourage 2.0Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied. | Behavioural | Intervention |
Primary outcome
Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
Time frame: 12 months
5 secondary outcomes
Hemoglobin A1C
Time frame: 12 months
Physical activity
Time frame: 12 months
Quality of life
Time frame: 12 months
Intervention group session attendance
Time frame: 12 months
Dietary records
Time frame: 12 months
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 7 Aug 2019.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Tamara Hannon, MD principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Encourage 2.0 in people with Diabetes Mellitus, Type 2 and Prediabetic State, run by Indiana University at 3 sites 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 8 inclusion and 1 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart (time frame: 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 7 Aug 2019.