A Culturally-tailored Personalized Nutrition Intervention in South Asian Women at Risk of Gestational Diabetes
NCT ID: NCT03607799
Last Updated: 2025-05-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
140 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-11-26
Study Completion Date
2025-12-31
Brief Summary
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This trial will assess the impact of a culturally tailored, personalized nutrition intervention on glycemic response to an oral glucose load (as measured by the area-under-the curve glucose) in high-risk pregnancies of South Asian women. The intervention targets two at-risk individuals: mother and infant, "breaking the cycle" of maternal gestational dysglycemia, excess infant adiposity and insulin resistance, and CVD in both mother and baby. The findings of this study will be important in guiding future evidence-based recommendations and public health policies to manage gestational glycemia in pregnant women at risk of GDM.
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Detailed Description
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The DESI-GDM study is a randomized study to assess the impact of a culturally tailored, personalized nutrition intervention on glycemic response to an oral glucose load in high-risk pregnancies of South Asian women. Eligible South Asian pregnant women will be randomized to intervention or control.
South Asians (SA), people whose ancestors are from India, Pakistan, Bangladesh, or Sri Lanka, are the largest non-white ethnic group in Canada, and are at high risk of type 2 diabetes mellitus (T2DM) and early cardiovascular disease (CVD). SA women have at least double the risk of gestational diabetes (GDM) of white European women, and risk factors for future T2DM in the offspring including higher birthweight, more adipose tissue, and reduced insulin sensitivity, are more common in SA infants of mothers with GDM than infants born to mothers without GDM.
Building on our findings from the South Asian prospective birth cohort (START), which identified diet as a key modifiable risk factor for GDM, we have developed a dietary intervention. The women we spoke with expressed a desire to learn more about healthy eating to prevent diabetes during pregnancy and were keen to use mobile health technology.
The objectives of this trial among pregnant women of South Asian descent are to:
1. Evaluate the effectiveness of a culturally-tailored personalized nutrition intervention delivered by a trained health coach to improve blood sugar levels in South Asian women to a greater extant than usual dietary advice.
2. Evaluate the effectiveness of a culturally-tailored personalized nutrition intervention delivered by a trained health coach to pregnant South Asian women in the reduction of the incidence of gestational diabetes mellitus to a greater extent than usual dietary advice.
The findings of this study will be important in guiding future evidence-based recommendations and public health policies to manage gestational glycemia in pregnant women at risk of GDM.
South Asians (SA), people whose ancestors are from India, Pakistan, Bangladesh, or Sri Lanka, are the largest non-white ethnic group in Canada, and are at high risk of type 2 diabetes mellitus (T2DM) and early cardiovascular disease (CVD). SA women have at least double the risk of gestational diabetes (GDM) of white European women, and risk factors for future T2DM in the offspring including higher birthweight, more adipose tissue, and reduced insulin sensitivity, are more common in SA infants of mothers with GDM than infants born to mothers without GDM.
Building on our findings from the South Asian prospective birth cohort (START), which identified diet as a key modifiable risk factor for GDM, we have developed a dietary intervention. The women we spoke with expressed a desire to learn more about healthy eating to prevent diabetes during pregnancy and were keen to use mobile health technology.
The objectives of this trial among pregnant women of South Asian descent are to:
1. Evaluate the effectiveness of a culturally-tailored personalized nutrition intervention delivered by a trained health coach to improve blood sugar levels in South Asian women to a greater extant than usual dietary advice.
2. Evaluate the effectiveness of a culturally-tailored personalized nutrition intervention delivered by a trained health coach to pregnant South Asian women in the reduction of the incidence of gestational diabetes mellitus to a greater extent than usual dietary advice.
The findings of this study will be important in guiding future evidence-based recommendations and public health policies to manage gestational glycemia in pregnant women at risk of GDM.
Conditions
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Diabetes, Gestational
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Human
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
Those assessing the primary and secondary clinical outcomes are masked to treatment assignment.
Study Groups
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Dietary Intervention
A personalized nutrition plan will be developed for each woman and will respect faith-based food choices and regional preferences. The plan will be delivered by a culturally congruent health coach, and consider baseline dietary intake, energy balance for recommended gestational weight gain, personal values and preferences, through setting 2-4 "SMART" goals. Participants assigned to the intervention group will receive text messages. Participants assigned to the intervention group will be given a Fitbit to track their steps and will receive simple text messages weekly, aimed at increasing walking. They will be given PDF resources that provide advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the South Asian community.
Group Type
EXPERIMENTAL
Dietary Intervention
Intervention Type
BEHAVIORAL
Individualized diet advice will be developed for each participant by a dietitian familiar with South Asian foods.
Control
Participants in the control group will receive simple text messages weekly, aimed at increasing walking. They will be given PDF resources that provide advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the South Asian community.
Group Type
ACTIVE_COMPARATOR
Control
Intervention Type
BEHAVIORAL
Control group participants will be provided with PDFs, website links to encourage healthy eating, physical activity, and other lifestyle factors during pregnancy. They will also receive weekly text messages aimed at increasing walking.
Interventions
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Dietary Intervention
Individualized diet advice will be developed for each participant by a dietitian familiar with South Asian foods.
Intervention Type
BEHAVIORAL
Control
Control group participants will be provided with PDFs, website links to encourage healthy eating, physical activity, and other lifestyle factors during pregnancy. They will also receive weekly text messages aimed at increasing walking.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* pregnant
* South Asian ancestry
* gestational week 12-18
* singleton pregnancy
* at least 2 of the following:
1. age \> 29
2. low diet quality (assessed with a short diet questionnaire)
3. family history of type 2 diabetes in first-degree relative
4. gestational diabetes during a previous pregnancy
5. pre-pregnancy body-mass-index ≥23.17
* South Asian ancestry
* gestational week 12-18
* singleton pregnancy
* at least 2 of the following:
1. age \> 29
2. low diet quality (assessed with a short diet questionnaire)
3. family history of type 2 diabetes in first-degree relative
4. gestational diabetes during a previous pregnancy
5. pre-pregnancy body-mass-index ≥23.17
Exclusion Criteria
* type 1 or type 2 diabetes
* high blood pressure (\>140 mm Hg systolic or \>90 mm Hg diastolic)
* poor understanding of English
* unwillingness to modify diet
* at high risk of adverse pregnancy outcomes other than gestational diabetes (e.g. twins or higher-order multiples, use of fertility treatment(s), pre-existing hypertension, history of placenta previa or pre-term birth)
* enrollment in another study
* does not have a smartphone
* not willing to walk
* excessive nausea and/or vomiting
* high blood pressure (\>140 mm Hg systolic or \>90 mm Hg diastolic)
* poor understanding of English
* unwillingness to modify diet
* at high risk of adverse pregnancy outcomes other than gestational diabetes (e.g. twins or higher-order multiples, use of fertility treatment(s), pre-existing hypertension, history of placenta previa or pre-term birth)
* enrollment in another study
* does not have a smartphone
* not willing to walk
* excessive nausea and/or vomiting
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Sponsor Role
collaborator
Population Health Research Institute
OTHER
Sponsor Role
collaborator
McMaster University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Russell J de Souza, ScD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Farah Khan
Hamilton, Ontario, Canada
Site Status
Countries
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Canada
References
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Reference Type
BACKGROUND
Mission JF, Ohno MS, Cheng YW, Caughey AB. Gestational diabetes screening with the new IADPSG guidelines: a cost-effectiveness analysis. Am J Obstet Gynecol. 2012 Oct;207(4):326.e1-9. doi: 10.1016/j.ajog.2012.06.048. Epub 2012 Jun 29.
Reference Type
BACKGROUND
Archambault C, Arel R, Filion KB. Gestational diabetes and risk of cardiovascular disease: a scoping review. Open Med. 2014 Jan 7;8(1):e1-9. eCollection 2014.
Reference Type
BACKGROUND
Stennett RN, Adamo KB, Anand SS, Bajaj HS, Bangdiwala SI, Desai D, Gerstein HC, Kandasamy S, Khan F, Lear SA, McDonald SD, Pocsai T, Ritvo P, Rogge A, Schulze KM, Sherifali D, Stearns JC, Wahi G, Williams NC, Zulyniak MA, de Souza RJ. A culturally tailored personaliseD nutrition intErvention in South ASIan women at risk of Gestational Diabetes Mellitus (DESI-GDM): a randomised controlled trial protocol. BMJ Open. 2023 May 2;13(5):e072353. doi: 10.1136/bmjopen-2023-072353.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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4886
Identifier Type: -
Identifier Source: org_study_id
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