Evidence-based Intervention for Diabetes Prevention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNew York University
About this trial
The goal of this behavioral intervention trial is to develop strategies to decrease the incidence of diabetes within the UAE. The investigators will investigate the effectiveness of a group-based telehealth intervention facilitated by a health coach in adults at risk for developing diabetes who live in the UAE.
The investigators will conduct a single-arm feasibility trial of the Evidence-based Intervention for Diabetes prevention among thirty adults with prediabetes. All participants will receive 12 weekly virtual intervention sessions over the course of three months, facilitated by a trained DPP lifestyle coach who is from the same cultural community and can deliver the material in either Arabic or English.
The primary feasibility measure is acceptability, as measured by intervention session attendance. Other outcome assessments will be conducted at baseline and three months at NYU Abu Dhabi, where study staff will assess weight, hemoglobin A1c, diet, and physical activity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women 18 years or older
Diabetes risk score > 5
BMI >=25kg/m²
Arabic or English speaking
Disqualifiers
Prevalent diabetes
Prior participation in a diabetes prevention program
Taking FDA-approved weight loss medications
Pregnant or lactating
Trial design
Design model
Single group
Treatments tested in this trial
Adapted diabetes prevention program
BehavioralThe intervention is based on the CDC Diabetes Prevention Program and has been adapted into a culturally appropriate intervention in an Arab context. The program has been condensed into 12 sessions with an additional session that addresses lifestyle factors during Ramadan. Each session covers a different topic related to diet, physical activity, sleep, and stress management. Additionally, the intervention includes written materials to help participants develop lifestyle goals and encourages them to seek social support. There are a series of 12 videos in Arabic and English that support the information delivered in the group sessions. In addition to the group sessions, participants will have access to the automated app and education materials.
App based support
BehavioralThis intervention will provide educational videos that have been culturally adapted to the Arab context and additional automated supports for lifestyle modification. Study participants will be provided with access to an app that they will be encouraged to engage with on a regular basis. The app will provide basic diet, physical activity, and lifestyle support to prevent diabetes. Participants will also be able to track activity, diet, and receive feedback on their personal weight, diet habits, and activity levels.
Patient education materials
BehavioralParticipants will be provided written or web-based diabetes prevention materials. These materials will provide basic tips on diet, physical activity and other lifestyle factors.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Group facilitated behavioral counseling armExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Intervention acceptability based on the proportion of sessions attended
Acceptability of the intervention will be measured by the number (%) of intervention sessions attended. Each participant will be offered 12 intervention sessions, and the acceptability of the intervention will be measured by the proportion of sessions attended (# sessions attended/ 12).
Time frame
3 months (post intervention)Secondary outcomes
1
Changes in glycemia
Changes in HbA1c at 3 months post baseline.
Time frame
0 and 3 monthsOther outcomes
1
Weight loss
Mean weight loss at 3 months post baseline.
Time frame
0 and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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