A culturally tailored personaliseD nutrition intErvention in South ASIan women at risk of Gestational Diabetes Mellitus (DESI-GDM): a randomised controlled trial protocol.
Study Goal
The researchers aimed to evaluate the effectiveness of a culturally tailored, personalized nutrition intervention combined with walking encouragement (via text messages and FitBit tracking) on glucose control in pregnant South Asian women at risk for gestational diabetes mellitus (GDM).
Results Summary
The study assessed the impact of walking encouragement alongside dietary interventions on glucose AUC during an OGTT and GDM diagnosis rates, but specific results regarding walking alone were not detailed in the abstract.
Population
Pregnant South Asian women (gestational weeks 12-18) with at least two GDM risk factors.
Effective Dosage
Encouragement via weekly text messages and FitBit tracking (specific step goals not mentioned).
Duration
6-16 weeks, depending on recruitment timing.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
culturally tailored, personalised nutrition intervention | neutral | glucose area under the curve (AUC) after a 2-hour 75 g oral glucose tolerance test (OGTT) | pregnant women of South Asian ancestry with GDM risk factors | - | evaluate the effectiveness | #1 |
culturally tailored, personalised nutrition intervention | neutral | glucose area under the curve (AUC) after a 2-hour 75 g oral glucose tolerance test (OGTT) | pregnant women of South Asian ancestry with GDM risk factors | - | evaluate the participant acceptability | #2 |
usual care, plus weekly text messages to encourage walking and paper handouts | neutral | glucose AUC from a three-sample 75 g OGTT | South Asian pregnant women with at least 2 GDM risk factors | - | - | #3 |
personalised nutrition plan developed and delivered by a culturally congruent dietitian and health coach; and FitBit to track steps | neutral | glucose AUC from a three-sample 75 g OGTT | South Asian pregnant women with at least 2 GDM risk factors | - | - | #4 |
usual care, plus weekly text messages to encourage walking and paper handouts | neutral | GDM diagnosis, based on Born-in-Bradford criteria (fasting glucose>5.2 mmol/L or 2 hours post load>7.2 mmol/L) | South Asian pregnant women with at least 2 GDM risk factors | - | - | #5 |
personalised nutrition plan developed and delivered by a culturally congruent dietitian and health coach; and FitBit to track steps | neutral | GDM diagnosis, based on Born-in-Bradford criteria (fasting glucose>5.2 mmol/L or 2 hours post load>7.2 mmol/L) | South Asian pregnant women with at least 2 GDM risk factors | - | - | #6 |
INTRODUCTION: South Asians are more likely to develop gestational diabetes mellitus (GDM) than white Europeans. Diet and lifestyle modifications may prevent GDM and reduce undesirable outcomes in both the mother and offspring. Our study seeks to evaluate the effectiveness and participant acceptability of a culturally tailored, personalised nutrition intervention on the glucose area under the curve (AUC) after a 2-hour 75 g oral glucose tolerance test (OGTT) in pregnant women of South Asian ancestry with GDM risk factors. METHODS AND ANALYSIS: A total of 190 South Asian pregnant women with at least 2 of the following GDM risk factors-prepregnancy body mass index>23, age>29, poor-quality diet, family history of type 2 diabetes in a first-degree relative or GDM in a previous pregnancy will be enrolled during gestational weeks 12-18, and randomly assigned in a 1:1 ratio to: (1) usual care, plus weekly text messages to encourage walking and paper handouts or (2) a personalised nutrition plan developed and delivered by a culturally congruent dietitian and health coach; and FitBit to track steps. The intervention lasts 6-16 weeks, depending on week of recruitment. The primary outcome is the glucose AUC from a three-sample 75 g OGTT 24-28 weeks' gestation. The secondary outcome is GDM diagnosis, based on Born-in-Bradford criteria (fasting glucose>5.2 mmol/L or 2 hours post load>7.2 mmol/L). ETHICS AND DISSEMINATION: The study has been approved by the Hamilton Integrated Research Ethics Board (HiREB #10942). Findings will be disseminated among academics and policy-makers through scientific publications along with community-orientated strategies. TRIAL REGISTRATION NUMBER: NCT03607799.