Type 2 DiabetesNCT02721602
Families Preventing Diabetes Together
A study testing Families Preventing Diabetes Together in people with Type 2 Diabetes and Pediatric Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
The current study proposes to study the feasibility and acceptability of the Families Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Read more about this study
- Who is it for?
- Ages 2 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Pediatric Obesity
- What is being tested?
- Families Preventing Diabetes Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 30 Jun 2017
- 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 2 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Parent with Type 2 diabetes
- At least 1 child between the ages of 7-12
- Parent has completed at least some Diabetes Education through Fairview Health System
Who cannot join
- Parent with Type 2 diabetes does not speak or read in English
- No parents with Type 2 diabetes or no children ages 7-12 years
- Parent with Type 2 diabetes has not completed at least some Diabetes Education
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, School of Nursing
Minneapolis, Minnesota, 55455
About this study
The current study proposes to study the feasibility and acceptability of the Families Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.
Read the detailed description
The current study is a randomized controlled trial with 40 families. Twenty families will be randomly assigned to receive usual care consisting of diabetes education delivered through Fairview Health Services. An additional 20 families will be randomized to a family-based, in-person program that focuses on nutrition education, the development of meal planning and cooking skills and promotion of healthful eating for families; the program will augment usual care and diabetes education received from Fairview Health Services for the parent with diabetes. Parents with diabetes who are randomized to the intervention group will also participate in one goal-setting phone call with intervention staff at one point during the intervention program.
Adult patients and their families will be recruited in two ways:
- from Fairview Health Service's clinics in the North metropolitan area with the assistance of Fairview Health Service diabetes educators, and
- through MyChart messages informing them about the study.
Adults between the ages of 25 and 55 years who have a diagnosis of Type 2 diabetes, who have participated in at least some diabetes education through Fairview Health Services, and who have at least one child between the ages of 7-12 years of age will be invited to participate in the study. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.
- Conditions
- Type 2 Diabetes, Pediatric Obesity
- Being tested
- Families Preventing Diabetes Together
- Medical subject headings
- Diabetes Mellitus, Type 2, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families Preventing Diabetes TogetherBehavioural
Families in the intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Families in the Families Preventing Diabetes Together intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period. Receives: Behavioral: Families Preventing Diabetes Together |
| Measurement Only | No intervention | No intervention only measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
Ability to successfully recruit 30- 40 families in the study will determine feasibility.
Measured: up to 6 months
Feasibility of the study measured via the ability to successfully measure 100% of the adults and 80% of the children in enrolled families at baseline measurements.
Ability to successfully measure 100% of recruited adults and 80% of children in enrolled families at baseline measurements will determine feasibility.
Measured: up to 6 months
Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
Measured: up to 6 months
Acceptability of the intervention measured via family participation rates (families attend at least 70% of the sessions).
Family participation in the intervention (attending at least 70% of sessions) will determine acceptability.
Measured: up to 6 months
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
Measured: up to 6 months
Secondary outcomes (2)
Child BMIz
Objectively measured height and weight will be used to determine child BMIz values to see if the study resulted in any changes in BMIz between baseline measurements and post-intervention measurements.
Measured: up to 6 months
Blood glucose control in parent with Type 2 diabetes
Change in type 2 diabetic parent's A1C values over the course of the study will be used to measure parent blood glucose control between baseline measurements and post-intervention measurements.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721602
- Sponsor's protocol ID
- 23085
- Status last verified
- Aug 2017
- First submitted
- 16 Feb 2016
- Last updated
- 24 Aug 2017
- 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 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families Preventing Diabetes Together
- ClinicalTrials.gov ID
- NCT02721602
- Acronym / sponsor ID
- 23085
- Conditions
- Type 2 Diabetes, Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 29 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.
The current study proposes to study the feasibility and acceptability of the Families Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.
Detailed description
The current study is a randomized controlled trial with 40 families. Twenty families will be randomly assigned to receive usual care consisting of diabetes education delivered through Fairview Health Services. An additional 20 families will be randomized to a family-based, in-person program that focuses on nutrition education, the development of meal planning and cooking skills and promotion of healthful eating for families; the program will augment usual care and diabetes education received from Fairview Health Services for the parent with diabetes. Parents with diabetes who are randomized to the intervention group will also participate in one goal-setting phone call with intervention staff at one point during the intervention program.
Adult patients and their families will be recruited in two ways:
- from Fairview Health Service's clinics in the North metropolitan area with the assistance of Fairview Health Service diabetes educators, and
- through MyChart messages informing them about the study.
Adults between the ages of 25 and 55 years who have a diagnosis of Type 2 diabetes, who have participated in at least some diabetes education through Fairview Health Services, and who have at least one child between the ages of 7-12 years of age will be invited to participate in the study. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Families Preventing Diabetes TogetherFamilies in the Families Preventing Diabetes Together intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period. |
| Measurement Only | No intervention | –No intervention only measurements |
Who may qualify
- Ages
- 2 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Parent with Type 2 diabetes
- At least 1 child between the ages of 7-12
- Parent has completed at least some Diabetes Education through Fairview Health System
Key exclusion criteria (3 listed)
- Parent with Type 2 diabetes does not speak or read in English
- No parents with Type 2 diabetes or no children ages 7-12 years
- Parent with Type 2 diabetes has not completed at least some Diabetes Education
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 |
|---|---|---|
| Families Preventing Diabetes TogetherFamilies in the intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period. | Behavioural | Intervention Group |
Primary outcome
Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
Time frame: up to 6 months
Ability to successfully recruit 30- 40 families in the study will determine feasibility.
Feasibility of the study measured via the ability to successfully measure 100% of the adults and 80% of the children in enrolled families at baseline measurements.
Time frame: up to 6 months
Ability to successfully measure 100% of recruited adults and 80% of children in enrolled families at baseline measurements will determine feasibility.
Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
Time frame: up to 6 months
Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
Acceptability of the intervention measured via family participation rates (families attend at least 70% of the sessions).
Time frame: up to 6 months
Family participation in the intervention (attending at least 70% of sessions) will determine acceptability.
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
Time frame: up to 6 months
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
2 secondary outcomes
Child BMIz
Time frame: up to 6 months
Blood glucose control in parent with Type 2 diabetes
Time frame: up to 6 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 24 Aug 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families Preventing Diabetes Together in people with Type 2 Diabetes and Pediatric Obesity, run by University of Minnesota 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 3 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 24 Aug 2017. 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?
Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study. (time frame: up to 6 months). The study lists 5 primary outcomes in all. 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 24 Aug 2017.