Clinical trial NCT03664089: Physical Activity Intervention for Gestational Diabetes
Official title: Physical Activity Intervention for Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Ohio Department of Health
name: Ohio State University
name: American Diabetes Association
First posted: 2018-09-10
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM). The increased risk associated with having GDM is compounded by excess weight retention. Therefore, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM. The long-term goal is to prevent T2DM among women with GDM. This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM.

Detailed description: Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM). The increased risk associated with having GDM is compounded by excess weight retention, a common issue after any pregnancy. Considering excess weight is the best predictor of developing T2DM, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM. The long-term goal is to prevent T2DM among women with GDM. This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM in a parallel two-arm randomized controlled trial (n=80 women/arm, N=160). The intervention uses ankle weights (2.5 pounds \[1.1 kg\]) worn on each ankle during routine daily activities (e.g., cleaning, cooking, child care) to increase energy expenditure. The central hypothesis, based on existing literature and preliminary data, is that postpartum women with GDM will adopt an intervention that requires minimal additional time outside of their daily activities. We anticipate that this will result in additional weight loss that is clinically significant when compared with controls who only receive standard information on recommended physical activity. The rationale for the proposed research is that once an intervention that both improves T2DM factors and is easily adopted by women with GDM is known, early intervention specific to this restricted timeframe can be implemented.

Eligibility criteria: Inclusion Criteria:

* Age 18+ years
* Diagnosed with GDM in current pregnancy
* English language ability adequate for participation
* Plan to remain in the area for study duration
* Ability to provide informed consent

Exclusion Criteria:

* Prior Type 1 or Type 2 diabetes
* Pregnant with multiples (e.g., twin, triplets, etc.)
* Premature infant \[\<35 completed weeks gestation (assessed after delivery, before randomization)\]
* Heart disease, serious illness, or conditions that may impede or prohibit participation in either study arm
* Pre-pregnancy BMI \<18.5 (underweight)
* Live outside 35 mile radius of Ohio State University
* Woman is an appointed surrogate
* Infant will be adopted after delivery

Primary outcomes:
measure: Weight loss
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Secondary outcomes:
measure: Body Fat %
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
measure: BMI
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
measure: Waist-hip Ratio
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
measure: Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Oral Glucose Tolerance Test (OGTT)
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
measure: Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: HOMA
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
measure: Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Hemoglobin A1c (HbA1c)
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
measure: Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Leptin
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
measure: Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: High sensitivity c-reactive protein (hs-CRP)
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
measure: Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Adiponectin
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
measure: Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Lipid Panel
timeFrame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Sarah Keim, PhD, MA, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stith BJ, Buls SM, Keim SA, Thung SF, Klebanoff MA, Landon MB, Gabbe SG, Gandhi KK, Oza-Frank R. Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial. BMC Pregnancy Childbirth. 2021 Jun 29;21(1):461. doi: 10.1186/s12884-021-03886-3.