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A Culturally-tailored Personalized Nutrition Intervention in South Asian Women at Risk of Gestational Diabetes (DESI-GDM)

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ClinicalTrials.gov Identifier: NCT03607799
Recruitment Status : Not yet recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
Population Health Research Institute
Information provided by (Responsible Party):
McMaster University

Brief Summary:
This study will assess the feasibility of delivering, and the effectiveness of a culturally-tailored personalized nutrition program to reduce gestational dysglycemia in women of South Asian ancestry living in Ontario. The trial will be deemed feasible if the investigators can recruit the desired sample within 2 years, retain >80% of participants and achieve at least 2 of 4 agreed-upon dietary goals in >80% of participants. The intervention will be deemed acceptable if >80% of participants would recommend the program to a friend. The primary clinical outcome of the trial is gestational dysglycemia, and the secondary outcomes are GDM, infant birthweight and adiposity, and obstetrical complications. The results of the feasibility, acceptability, and clinical outcome assessments of this study will be used to plan a full-scale study to assess whether a culturally-tailored personalized nutrition program can reduce GDM in this population.

Condition or disease Intervention/treatment Phase
Diabetes, Gestational Behavioral: Dietary Intervention Behavioral: Control Not Applicable

Detailed Description:

South Asians, people whose ancestors originate from India, Pakistan, Bangladesh, or Sri Lanka, are the largest and fastest growing non-white ethnic group in Canada, and are at particularly high risk of type 2 diabetes (T2DM) and premature cardiovascular disease (CVD). Gestational diabetes (GDM), a type of diabetes that occurs during pregnancy, affects 3% of pregnancies, but 12% of pregnancies in women of South Asian descent. Untreated, gestational diabetes can increase the risk of macrosomia, and maternal and offspring risks of obesity and type 2 diabetes. In our South Asian prospective birth cohort (START), we have shown that, compared to white Caucasian women, pregnant South Asian women: i) have an increased risk of elevated blood glucose and GDM; and ii) are more likely to give birth to infants of lower weight but greater adiposity. Lower birth weight and more adipose infants are more likely to become insulin-resistant during adolescence and develop T2DM as adults. Therefore, interventions that optimize glycemia in pregnancy may reduce the risk of GDM as well as lower the risk of T2DM and atherosclerosis in mothers and their offspring in adult life.

Diet is an important modifiable risk factor for hyperglycemia and GDM, but there is uncertainty about the optimal method of delivering an intervention in a South Asian population. Barriers to healthy eating during pregnancy for South Asian women include: i) changing long-held cultural diet practices; ii) difficulty adapting standard dietary advice to personal health beliefs; iii) navigating food choices at family gatherings; and iv) accommodating meal needs of others in the household.

The study will advance the understanding of effective and acceptable dietary modifications to reduce gestational dysglycemia (as measured by the area under the curve of glucose) in pregnant South Asian women, a high-risk segment of the Canadian population. The investigators will evaluate the feasibility of delivering a culturally-tailored, personalized nutrition intervention program to high-risk South Asian women in Peel region, Ontario. The intervention is guided by the team's previous research in South Asian communities and pregnant women and grounded in qualitative work with women and their health care providers. The objectives of this pilot trial among pregnant women of South Asian descent are to:

  1. Evaluate the feasibility of delivering a culturally-tailored nutrition intervention program to pregnant South Asian women, living in Peel region, Ontario.
  2. Evaluate the effectiveness of a culturally-tailored nutrition program to improve gestational dysglycemia (as measured by the incremental area-under-the-curve [AUC] of glucose, the primary clinical outcome) and reduce gestational diabetes (secondary, exploratory outcome)
  3. Evaluate the effectiveness of a culturally-tailored nutrition program on infant anthropometrics (e.g. birth weight and length, and skinfold thickness; secondary, exploratory outcomes)

The results of the feasibility, acceptability, and clinical outcome assessments of our study will be used to plan a future, full-scale study to assess whether a culturally-tailored personalized nutrition program can reduce GDM in this population.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Human
Masking: Single (Outcomes Assessor)
Masking Description: Those assessing the primary and secondary clinical outcomes are masked to treatment assignment.
Primary Purpose: Prevention
Official Title: Developing and Testing a Culturally-tailored Personalized Nutrition Intervention in South Asian Women at Risk of Gestational Diabetes
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dietary Intervention
A dietitian develops personalized diet advice for each intervention group participant. She sets 2-4 "SMART" goals according to the following principles: 1) Replace fried foods and meat with vegetable protein, raw and cooked vegetables; 2) Reduce refined carbohydrate intake; 3) Improve carbohydrate quality (replace high glycemic index, refined grain foods with lower glycemic index, whole-grain foods; 4) Reduce trans fats; 5) Schedule regular mealtimes, 3-4 hours apart; 6) Reduce high-carbohydrate snacks; 7) Reduce desserts and/or drinks high in starch and sugar. Participants review 6 simple messages at the baseline visit, aimed at increasing walking, with "reinforcement" text messages sent weekly.
Behavioral: Dietary Intervention
Individualized diet advice will be developed for each participant by a dietitian familiar with South Asian foods.

Active Comparator: Control
Control group participants will be provided with paper copies and website links to "The Sensible Guide to a Healthy Pregnancy", which provides advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the SA community. Participants review 6 simple messages at the baseline visit, aimed at increasing walking, with "reinforcement" text messages sent weekly.
Behavioral: Control
Control group participants will be provided with paper copies and website links to "The Sensible Guide to a Healthy Pregnancy", which provides advice on healthy eating, physical activity, and other lifestyle factors during pregnancy.




Primary Outcome Measures :
  1. area-under-the-curve of glucose [ Time Frame: 3 months ]
    A measure of glycemic response, AUC glucose is a continuous measure of the response to a 75-g oral glucose tolerance test, and is calculated by the trapezoidal method using the fasting, 1-h, and 2-h glucose.

  2. completeness of oral glucose-tolerance test (OGTT) measure [ Time Frame: 4 months ]
    This is an indicator of how feasible it is for us to collect the primary outcome measure in the women we have enrolled. If >=90% of participants who start the study provide the OGTT at the final visit, this outcome will be considered feasible to collect.

  3. acceptability of the intervention to the participants [ Time Frame: 5 months ]
    This is an indicator of whether women in the trial found the intervention to be acceptable. This information will be collected as part of a post-study qualitative interview. If >=80% of women who complete the study would recommend the intervention to a friend, the program will be considered to be broadly acceptable to the target population of women.

  4. study completion rate [ Time Frame: 5 months ]
    This is an indicator of how feasible it is to collect data from both the woman and her baby. If >=80% of participants who begin the study provide the oral glucose tolerance test measure as well as complete the infant assessment, the collection of maternal and offspring outcomes will be considered feasible.


Secondary Outcome Measures :
  1. gestational diabetes mellitus [ Time Frame: 3 months ]
    Gestational diabetes mellitus is classified using the cut-offs derived in a large cohort of South Asian women from the "Born in Bradford" cohort: fasting glucose level >= 5.2 mmol/L, or 2-hour post-load level >=7.2 mmol/L.

  2. birthweight [ Time Frame: 4 months ]
    Measured at delivery, to the nearest 10 g on a digital weigh scale

  3. sum-of-skinfolds [ Time Frame: 4 months ]
    Measured at delivery, to the nearest 0.2 mm using skin-fold calipers. Skin-folds measures are used to predict body density, from which body fat and fat free mass (FFM) is estimated using prediction equations.

  4. birth length [ Time Frame: 4 months ]
    Measured to the nearest cm. An indicator of infant growth.

  5. Cesarean section [ Time Frame: 4 months ]
    We will count the proportion of women who require a Cesarean section (planned or unplanned) from the birth chart. A measure of obstetrical complication.

  6. Shoulder dystocia [ Time Frame: 4 months ]
    We will count the proportion of babies who experience shoulder dystocia from the birth chart. A measure of obstetrical complication.

  7. infant mortality [ Time Frame: up to 1 year post-partum ]
    We will calculate the infant mortality proportion as: the number of infants who are stillborn or who die within 1 year of birth, divided by the number of live births.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant
  • South Asian ancestry (both parents and all four grandparents originate from India, Pakistan, Bangladesh or Sri Lanka)
  • gestational week 13-14
  • 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 (kg/m^2) >23.0

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 or unable to attempt to modify diet
  • at 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, and others at the PI's discretion)
  • any contraindication to walking during pregnancy
  • enrollment in another study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607799


Contacts
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Contact: Dipika Desai, MSc 9055212100 ext 40433 dipika.desai@phri.ca
Contact: Natalie C Williams, MLIS 9055259140 ext 26858 natcampb@mcmaster.ca

Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S4K1
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Population Health Research Institute
Investigators
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Principal Investigator: Russell J de Souza, ScD McMaster University

Publications:
The Social Planning Council of Peel. An exploratory study of diabetes among South Asians in Peel. Peel, ON, 2015.
Morency J-D, Malenfant EC, MacIssac S. Immigration and Diversity: Population Projections for Canada and its Regions, 2011 to 2036. Ottawa, ON: Statistics Canada;2017.

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03607799     History of Changes
Other Study ID Numbers: 4886
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will need to ask each participant if she will consent to this. Thus, we are uncertain to what extent we will be able to share individual participant data (IPD).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by McMaster University:
South Asian
diet

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications