Lifestyle Modification to Improve Diet in Women With GDM
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|ClinicalTrials.gov Identifier: NCT03669887|
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Diabetes Childhood Obesity Diabetes Mellitus||Behavioral: Lifestyle Modification Program||Not Applicable|
A complex intervention based on a proven lifestyle modification program (LMP) will be delivered to participants randomized to the intervention arm, starting in the early postnatal period. The intervention will consist of individualized face-to-face counseling on diet and weight management, meeting with exercise instructor, followed by telephone contact.
Control will receive standard postnatal education materials and usual care provided by government health service.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||317 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Clinical Trial Using a Postnatal Lifestyle Modification Program to Improve Diet, Adiposity and Metabolic Outcome in Mothers With Gestational Diabetes and Their Offspring|
|Actual Study Start Date :||September 12, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
|Experimental: Lifestyle Modification Program||
Behavioral: Lifestyle Modification Program
The intervention will consist of 5 individual face-to-face sessions at 2-weekly intervals with a dietitian with experience in lifestyle modification program, followed by monthly phone contact and smartphone text messages. All study participants in the intervention arm will also be arranged to meet with an exercise instructor at least once during the LMP on the same day as one of the dietitian appointment. Ongoing support from the exercise instructor will also be available by phone calls or emails.
|No Intervention: Control|
- Proportion achieving body weight goal [ Time Frame: Baseline, 12 months ]3% body weight change at 12 months if pre-pregnant BMI ≥ 23kg/m2, or for those with pre-pregnant BMI <23 kg/m2, either back to pre-pregnant weight or maintaining within BMI <23 kg/m2
- Change in diabetes risk [ Time Frame: Baseline, 12 months ]Measured by a validated risk score calculator (RUBY- Risk Understanding By Yourself)
- Changes in fasting glucose [ Time Frame: Baseline, 12 months ]Measured by OGTT (changes in mmol/l)
- Changes in physical activity [ Time Frame: Baseline, 12 months ]Measured by International Physical Activity Questionnaires (IPAQ) Total 7 questions on physical activity frequency according to intensity of the physical activity. Higher score indicates more physical activity.
- Changes in quality of life indices [ Time Frame: Baseline, 12 months ]Measured by Patient Health Questionnaire (PHQ-9) total score 27. Higher score indicates greater severity of depression. (Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.)
- % of achieving dietary intervention goal [ Time Frame: Baseline, 8weeks, 12 months ]Measured by a 3-day food intake record
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): NCT03669887
|Contact: Ronald C Ma, MBBChir,FRCPemail@example.com|
|Contact: Kit Tsoi, MScfirstname.lastname@example.org|
|Prince of Wales Hosptial||Recruiting|
|Shatin, Hong Kong|
|Principal Investigator:||Ronald C Ma, MBBChir,FRCP||Chinese University of Hong Kong|