HOPE for grandmother caregivers enrolled in a diabetes prevention program
| ISRCTN | ISRCTN17156057 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17156057 |
| Secondary identifying numbers | 11-21-ICTSHD-48 |
- Submission date
- 20/02/2025
- Registration date
- 21/02/2025
- Last edited
- 21/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
African American (AA) grandmothers play a vital role in their families, often serving as primary caregivers for their grandchildren. Many of these grandmothers are overweight or obese, which can affect their health and the health of their grandchildren. The Healthy Outcomes through Peer Educators (HOPE) study aims to help AA grandmother caregivers make healthier lifestyle choices and positively influence their grandchildren's health. The study tests a community-based, peer support diabetes prevention program (DPP) where grandmothers support each other in making these changes.
Who can participate?
AA grandmothers who are 40 years or older and serve as primary caregivers for their grandchildren can participate. They must also meet certain health criteria, including being overweight or obese and being at risk for diabetes.
What does the study involve? (for participants)
Participants will be assigned to one of two groups: the DPP group or the DPP plus HOPE group. The DPP plus HOPE group will receive additional support from a peer educator who will meet with them in person or by phone every week for one year. The study aims to help participants eat healthier, become more active, lose weight, and set a good example for their families.
What are the possible benefits and risks of participating?
Participants may benefit from improved health, weight loss, and better lifestyle habits. They may also positively influence their grandchildren's health. Risks could include the time commitment required for the program and potential challenges in making lifestyle changes.
Where is the study run from?
University of Wisconsin–Madison (USA)
When is the study starting and how long is it expected to run for?
March 2021 to January 2025
Who is funding the study?
American Diabetes Association
Who is the main contact?
Prof. Eva Vivian, eva.vivian@wisc.edu
Contact information
Public, Scientific, Principal Investigator
University of Wisconsin–Madison
777 Highland Avenue
Madison
53705
United States of America
 ORCID ID |
0000-0003-4648-5448 |
|---|---|
| Phone | +1 608-263-1779 |
| eva.vivian@wisc.edu |
Study information
| Study design | Prospective randomized feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Healthy Outcomes through Peer Educators |
| Study acronym | HOPE |
| Study objectives | Grandmother caregivers at risk for diabetes who received ongoing support from peers are more likely to successfully complete the Diabetes Prevention Program and model healthy behaviors that influence the health behaviors of family members particularly their grandchildren. |
| Ethics approval(s) |
Approved 12/03/2021, Social Sciences Human Subjects Protection Committee (University Bay Office Building Suite 105 800 University Bay Drive, Madison, 53705, United States of America; +1 608-263-2362; AskTheIRB@hsirb.wisc.edu), ref: 2021-1504 |
| Health condition(s) or problem(s) studied | Prevention of diabetes in grandmother caregivers with prediabetes |
| Intervention | This is a prospective randomized study to assess feasibility of diabetes prevention program (DPP) + HOPE relative to the active comparator (DPP only). Grandmother caregivers were randomized in a 2:1 ratio to DPP (active comparator) or DPP plus HOPE (intervention). DPP + HOPE incorporated support from a peer educator who met with participants in person or by phone every week during the one-year intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Outcome assessment, and intervention adherence rates assessed quantitatively 2. Grandchildren’s perspective of impact of grandmother’s health behaviors on their own health will be assessed (measured ) using semi-structured interviews conducted at the end of the 12-month study |
| Secondary outcome measures | 1. Changes in physical activity (steps per day) measured using Fitbit watch at end of 12 month study 2. Body weight (kg) measured at months 0, 6 and 12 |
| Overall study start date | 12/03/2021 |
| Completion date | 30/01/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 100 Years |
| Sex | Female |
| Target number of participants | 80 |
| Total final enrolment | 71 |
| Key inclusion criteria | 1. 40 years of age or older and the primary caregiver of one or more grandchildren. A primary caregiver was defined as “one who provides instrumental and expressive care to a grandchild on a daily basis for an indefinite period of time.” 2. Grandmothers were also required to meet DPP eligibility requirements at the time of enrollment in the study, which includes: 2.1. Having overweight or obesity (BMI greater than or equal to 25 kg/m²). 2.2. No previous diagnosis of diabetes. 2.3. A glycosylated hemoglobin A1C (A1C) between 5.7% to 6.4% (39 mmol/mol-46 mmol/mol) measured using a finger stick test at the time of enrollment. |
| Key exclusion criteria | Grandmothers were excluded if they were pregnant or had diseases that would limit their life span and ability to participate in the study. |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 01/03/2024 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Milwaukee
53209
United States of America
Milwaukee
53218
United States of America
Milwaukee
53209
United States of America
Madison
53719
United States of America
Sponsor information
Research organisation
2451 Crystal Drive, Suite 900
Arlington
22202
United States of America
| Phone | +1 800-342-2383 |
|---|---|
| askADA@diabetes.org | |
| Website | http://www.diabetes.org/ |
"ROR" |
https://ror.org/04f6cgz95 |
Funders
Funder type
Research organisation
Government organisation / Associations and societies (private and public)
- Alternative name(s)
- Asociación Americana de la Diabetes, American Diabetes Association, Inc., American Diabetes Assn, AmDiabetesAssn, ADA
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzes during the current study will be available upon request from Eva Vivian, eva.vivian@wisc.edu |
Editorial Notes
20/02/2025: Trial's existence confirmed by University of Wisconsin–Madison.
