Gestational DiabetesGDMNCT03664089
Physical Activity Intervention for Gestational Diabetes
A study testing Ankle weights (2.5 pounds [1.1 kg]/ankle) in people with Gestational Diabetes, run by Sarah Keim at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Ankle weights (2.5 pounds [1.1 kg]/ankle)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Ankle weights (2.5 pounds [1.1 kg]/ankle), Control
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle weights (2.5 pounds [1.1 kg]/ankle)Behavioural
Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), documentation for ankle weight usage, an accelerometer, and instructions for accelerometer usage.
ControlBehavioural
Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), instructions on ankle weight usage (wear during normal activity for 2 hours/day, 7 days/week). The weight type and weight amount were chosen based on previously published literature and used in our preliminary work. Receives: Behavioral: Ankle weights (2.5 pounds [1.1 kg]/ankle) |
| Control | Placebo comparator | All women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Postpartum weight loss will be defined as weight change from initial weigh-in at NCH Visit 1 to final weigh-in at NCH Visit 2. Weight will be measured in person using the Tanita.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Secondary outcomes (10)
Body Fat %
Percent body fat will be defined as the change in initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. Percent body fat will be measured in person using the Tanita.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
BMI
BMI will be defined as the change from initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. BMI will be measured using the Tanita for weight and obstetric medical record for height.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Waist-hip Ratio
Waist circumference (cm) will be assessed at the middle point between the ribs and the iliac crest, with the participant standing. Hip circumference (cm) will be measured at the widest circumference of the buttocks. Change in circumference will be defined as the change from initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. Waist-hip ratio will be measured in person using metric cloth tape.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Oral Glucose Tolerance Test (OGTT)
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. A fasting 2-hour, 75g OGTT will be conducted during both NCH visits. Glucose tolerance will be measured in mg/dL.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: HOMA
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. Insulin sensitivity (β-cell function) will be measured using the Matsuda index and HOMA-IR. Matsuda index score and HOMA-IR will be determined based on insulin values (μU/mL) and glucose values (mg/dL) obtained from the OGTT.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Hemoglobin A1c (HbA1c)
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. HbA1c will be analyzed as a percentage.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Leptin
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. Fasting serum leptin will be measured in ng/mL.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: High sensitivity c-reactive protein (hs-CRP)
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. hsCRP will be measured in mg/L.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Adiponectin
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. Adiponectin will be measured in µg/mL.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Lipid Panel
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. Lipids will be analyzed including total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides. Lipids will be measured in mg/dL.
Measured: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start10 Sep 2018
- Primary completion22 Feb 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Keim
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio Department of Health, Ohio State University, American Diabetes Association
- Responsible party
- Sponsor-investigator, Sarah Keim, Nationwide Children's Hospital
- Investigators
- Sarah Keim, PhD, MA, MS, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664089
- Sponsor's protocol ID
- 18-00178
- Acronym
- GDM
- Status last verified
- Jul 2022
- First submitted
- 5 Sep 2018
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Racke CA, Keim SA, Yisahak SF, Stith BJ, Thung SF, Klebanoff MA, Gabbe SG, Landon MB, Oza-Frank R. Postpartum Physical Activity Intervention Among Women With Gestational Diabetes: A Randomized Controlled Trial. Am J Lifestyle Med. 2025 Jun 14;20(6):930-940. doi: 10.1177/15598276251351809. eCollection 2026 Aug.
PubMed 40535905Stith 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.
PubMed 34187391
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Intervention for Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03664089
- Acronym / sponsor ID
- GDM / 18-00178
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sarah KeimUniversity, hospital or other
- Collaborators
- Ohio Department of Health, Ohio State University, American Diabetes Association
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Ankle weights (2.5 pounds [1.1 kg]/ankle)Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), instructions on ankle weight usage (wear during normal activity for 2 hours/day, 7 days/week). The weight type and weight amount were chosen based on previously published literature and used in our preliminary work. |
| Control | Placebo comparator | Behavioral: ControlAll women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle weights (2.5 pounds [1.1 kg]/ankle)Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), documentation for ankle weight usage, an accelerometer, and instructions for accelerometer usage. | Behavioural | Intervention |
| ControlWomen will receive the standard recommendation for engaging in 150 minutes of physical activity per week. | Behavioural | Control |
Primary outcome
Weight loss
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Postpartum weight loss will be defined as weight change from initial weigh-in at NCH Visit 1 to final weigh-in at NCH Visit 2. Weight will be measured in person using the Tanita.
10 secondary outcomes
Body Fat %
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
BMI
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Waist-hip Ratio
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Oral Glucose Tolerance Test (OGTT)
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: HOMA
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Hemoglobin A1c (HbA1c)
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Leptin
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: High sensitivity c-reactive protein (hs-CRP)
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Adiponectin
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Lipid Panel
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 40535905Racke CA, Keim SA, Yisahak SF, Stith BJ, Thung SF, Klebanoff MA, Gabbe SG, Landon MB, Oza-Frank R. Postpartum Physical Activity Intervention Among Women With Gestational Diabetes: A Randomized Controlled Trial. Am J Lifestyle Med. 2025 Jun 14;20(6):930-940. doi: 10.1177/15598276251351809. eCollection 2026 Aug.
- Derived from this study: PubMed 34187391Stith 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Keim, PhD, MA, MS principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle weights (2.5 pounds [1.1 kg]/ankle) in people with Gestational Diabetes, run by Sarah Keim at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03664089, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.