Diabetes Mellitus RiskSHAPE-UpNCT03526237
Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes
A study testing 24 week community based DPP Group Lifestyle Balance Program in people with Diabetes Mellitus Risk and Obesity, run by Medical University of South Carolina.
Trial summary
(Sisters Health And Primary CarE Uniting and Preventing Diabetes; aka SHAPE UP) will consist of: 1) Neighborhood DPP Intervention: group DPP sessions and individual coaching; 2) Preventive Care Coordination to FQHC: referral, navigation assistance, patient activation, linkage to primary care (community initiated… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Risk, Obesity, Cardiovascular Risk Factor
- What is being tested?
- 24 week community based DPP Group Lifestyle Balance Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 24 Apr 2015to 1 Jul 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 years of age or older
- Body-mass index of > 25 kg/m2 or waist circumference >35 inches
- ADA diabetes risk assessment > at risk for pre-diabetes
- Casual capillary blood glucose > 110 mg/dl <200
- Access to phone
- Resident in or surrounding partnering Public Housing neighborhood and eligible for FHCN services
Who cannot join
- Exclusions for diseases likely to limit lifespan and/or increase risk of interventions: a) Cancer requiring treatment in the past 5 years; b) Cardiovascular disease: "Yes" response to any item on the modified Physical Activity Readiness Questionnaire; Uncontrolled hypertension: SBP >180 mmHg or DBP >105 mmHg; Heart attack, stroke, or transient ischemic attack in the past 6 months; c) Lung disease: Chronic obstructive airways disease or asthma requiring home oxygen
- Exclusions related to metabolism: a) Diabetes at baseline; b) Casual capillary blood glucose >200 mg/dl; c) History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes; d) Pregnant female; e) Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
- Exclusion for conditions or behaviors likely to affect the conduct of the study: a) Unable or unwilling to provide informed consent; b) Unable to read written English
About this study
(Sisters Health And Primary CarE Uniting and Preventing Diabetes; aka SHAPE UP) will consist of: 1) Neighborhood DPP Intervention: group DPP sessions and individual coaching; 2) Preventive Care Coordination to FQHC: referral, navigation assistance, patient activation, linkage to primary care (community initiated referrals) and linkage to DPP program (FQHC initiated referrals)
Read the detailed description
SHAPE-UP we will use a randomized between groups wait-list design wherein the experimental treatment will be compared to best practices FHCN/FQHC services waitlist control (with an educational supplement for control). At the 24-week point, the waitlist control participants will be invited to receive the intervention. This combines a between groups RCT design with a phase change/within-group design for maximum efficiency with a limited N. Randomization will occur at the level of the individual participant. To sustain participant interest and to address obesity-related needs, control arm participants will receive Best Practices services including 1) Individual counseling about pre-diabetes risk at baseline; 2) mailed written materials at weeks 6, 12, 18; and 3) As needed additional FQHC Primary Care services (as mentioned, referral to the DPP obesity intervention and FHCN/FQHC primary care services will be bidirectional. The RE-AIM framework will guide process and impact evaluation measures of this intervention.
- Conditions
- Diabetes Mellitus Risk, Obesity, Cardiovascular Risk Factor
- Being tested
- 24 week community based DPP Group Lifestyle Balance Program, Wait-List Control community based DPP Group Lifestyle Balance Program
- Keywords
- diabetes, prevention, risk, obesity, weight loss, community based
- Medical subject headings
- Obesity, Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 week community based DPP Group Lifestyle Balance ProgramBehavioural
- 12 weekly peer group (adapted Group Lifestyle Balance Program) sessions followed by 3 monthly group maintenance sessions held in Public Housing locations; b) Individual coaching and patient activation during 24 week period; 2) Community Outreach Care Coordination: Referral, navigation assistance, patient activation, and cross-linkage to FQHC services.
Wait-List Control community based DPP Group Lifestyle Balance ProgramBehavioural
Control arm participants will receive: 1) Usual care in FQHC/primary care clinic 2) Individual counseling about pre-diabetes risk at baseline; mailed written NIDDK patient education materials (weight loss, physical activity, nutrition) at weeks 6, 12, 18; 2) At the end of the 24 week intervention, the wait list control arm will be invited to participate and receive the group based DPP sessions.
| Study group | Role | What they receive |
|---|---|---|
| The 24-week treatment | Experimental | The 24-week treatment, Sisters Health And Primary CarE Uniting and Preventing Diabetes (SHAPE UP) 12 weekly peer group (adapted Group Lifestyle Balance Program) sessions followed by 3 monthly group maintenance sessions held in Public Housing locations; b) Individual coaching and patient activation during 24 week period; 2) Community Outreach Care Coordination: Referral, navigation assistance, patient activation, and cross-linkage to FQHC services. Receives: Behavioral: 24 week community based DPP Group Lifestyle Balance Program |
| Wait-list Control | Other | Control arm participants will receive: 1) Usual care in FQHC/primary care clinic 2) Individual counseling about pre-diabetes risk at baseline; mailed written NIDDK patient education materials (weight loss, physical activity, nutrition) at weeks 6, 12, 18; 2) At the end of the 24 week intervention, the wait list control arm will be invited to participate and receive the group based DPP sessions. Receives: Behavioral: Wait-List Control community based DPP Group Lifestyle Balance Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
weight and height will be combined to report BMI in kg/m^2)
Measured: Wk. 12 and 24
Secondary outcomes (4)
Change in Waist circumference
waist (abdominal) circumference in centimeters
Measured: Wk 12 and 24
Change in Lipids (LDL, HDL, Total Cholesterol and Triglycerides)
Measured using a capillary blood sample Cholestech LDX
Measured: Wk. 12 and 24
Change in A1C
Measured using a capillary blood sample DCA 2000 analyzer
Measured: Wk 12 and 24
Change in Diet and exercise Behaviors
Assessed by the Health Promoting Lifestyle Profile II
Measured: Wk 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start24 Apr 2015
- Primary completion30 Sep 2016
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus RiskStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gayenell S Magwood, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526237
- Sponsor's protocol ID
- 00036688
- Other IDs
- 1R34DK097724
- Acronym
- SHAPE-Up
- Status last verified
- Apr 2020
- First submitted
- 29 Mar 2018
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Intervention Linking Public Housing With Primary Care to Prevent Diabetes
- ClinicalTrials.gov ID
- NCT03526237
- Acronym / sponsor ID
- SHAPE-Up / 00036688
- Conditions
- Diabetes Mellitus Risk, Obesity, Cardiovascular Risk Factor
- Keywords
- diabetes, prevention, risk, obesity, weight loss, community based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 24 Apr 2015 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 16 May 2018 (actual)
- 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.
(Sisters Health And Primary CarE Uniting and Preventing Diabetes; aka SHAPE UP) will consist of: 1) Neighborhood DPP Intervention: group DPP sessions and individual coaching; 2) Preventive Care Coordination to FQHC: referral, navigation assistance, patient activation, linkage to primary care (community initiated referrals) and linkage to DPP program (FQHC initiated referrals)
Detailed description
SHAPE-UP we will use a randomized between groups wait-list design wherein the experimental treatment will be compared to best practices FHCN/FQHC services waitlist control (with an educational supplement for control). At the 24-week point, the waitlist control participants will be invited to receive the intervention. This combines a between groups RCT design with a phase change/within-group design for maximum efficiency with a limited N. Randomization will occur at the level of the individual participant. To sustain participant interest and to address obesity-related needs, control arm participants will receive Best Practices services including 1) Individual counseling about pre-diabetes risk at baseline; 2) mailed written materials at weeks 6, 12, 18; and 3) As needed additional FQHC Primary Care services (as mentioned, referral to the DPP obesity intervention and FHCN/FQHC primary care services will be bidirectional. The RE-AIM framework will guide process and impact evaluation measures of this intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The 24-week treatment | Experimental | Behavioral: 24 week community based DPP Group Lifestyle Balance ProgramThe 24-week treatment, Sisters Health And Primary CarE Uniting and Preventing Diabetes (SHAPE UP) 12 weekly peer group (adapted Group Lifestyle Balance Program) sessions followed by 3 monthly group maintenance sessions held in Public Housing locations; b) Individual coaching and patient activation during 24 week period; 2) Community Outreach Care Coordination: Referral, navigation assistance, patient activation, and cross-linkage to FQHC services. |
| Wait-list Control | Other | Behavioral: Wait-List Control community based DPP Group Lifestyle Balance ProgramControl arm participants will receive: 1) Usual care in FQHC/primary care clinic 2) Individual counseling about pre-diabetes risk at baseline; mailed written NIDDK patient education materials (weight loss, physical activity, nutrition) at weeks 6, 12, 18; 2) At the end of the 24 week intervention, the wait list control arm will be invited to participate and receive the group based DPP sessions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 21 years of age or older
- Body-mass index of > 25 kg/m2 or waist circumference >35 inches
- ADA diabetes risk assessment > at risk for pre-diabetes
- Casual capillary blood glucose > 110 mg/dl <200
- Access to phone
Key exclusion criteria (3 listed)
- Exclusions for diseases likely to limit lifespan and/or increase risk of interventions: a) Cancer requiring treatment in the past 5 years; b) Cardiovascular disease: "Yes" response to any item on the modified Physical Activity Readiness Questionnaire; Uncontrolled hypertension: SBP >180 mmHg or DBP >105 mmHg; Heart attack, stroke, or transient ischemic attack in the past 6 months; c) Lung disease: Chronic obstructive airways disease or asthma requiring home oxygen
- Exclusions related to metabolism: a) Diabetes at baseline; b) Casual capillary blood glucose >200 mg/dl; c) History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes; d) Pregnant female; e) Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
- Exclusion for conditions or behaviors likely to affect the conduct of the study: a) Unable or unwilling to provide informed consent; b) Unable to read written English
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 |
|---|---|---|
| 24 week community based DPP Group Lifestyle Balance Programa) 12 weekly peer group (adapted Group Lifestyle Balance Program) sessions followed by 3 monthly group maintenance sessions held in Public Housing locations; b) Individual coaching and patient activation during 24 week period; 2) Community Outreach Care Coordination: Referral, navigation assistance, patient activation, and cross-linkage to FQHC services. | Behavioural | The 24-week treatment |
| Wait-List Control community based DPP Group Lifestyle Balance ProgramControl arm participants will receive: 1) Usual care in FQHC/primary care clinic 2) Individual counseling about pre-diabetes risk at baseline; mailed written NIDDK patient education materials (weight loss, physical activity, nutrition) at weeks 6, 12, 18; 2) At the end of the 24 week intervention, the wait list control arm will be invited to participate and receive the group based DPP sessions. | Behavioural | Wait-list Control |
Primary outcome
Change in BMI
Time frame: Wk. 12 and 24
weight and height will be combined to report BMI in kg/m^2)
4 secondary outcomes
Change in Waist circumference
Time frame: Wk 12 and 24
Change in Lipids (LDL, HDL, Total Cholesterol and Triglycerides)
Time frame: Wk. 12 and 24
Change in A1C
Time frame: Wk 12 and 24
Change in Diet and exercise Behaviors
Time frame: Wk 12 and 24
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 4 May 2020.
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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.
Gayenell S Magwood, PhD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing 24 week community based DPP Group Lifestyle Balance Program in people with Diabetes Mellitus Risk and Obesity, run by Medical University of South Carolina.
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 6 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 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 in BMI (time frame: Wk. 12 and 24). 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 4 May 2020.