NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks

Overweight or Obesity Clinical Trial

Official title:

NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674799
• Other study ID #: IRB00108429
• Secondary ID: 1R01DK130900-01A
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2023
• Est. completion date: May 31, 2028

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Katherine A Sauder, PhD
• Phone: 336-716-1280
• Email: ksauder[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) that is tailored to young women in childbearing years. The investigators will recruit 360 women aged 18-39 years with overweight/obesity who are not currently pregnant, but likely to conceive within 24 months. Women will be randomized to NDPP-NextGen or a usual care control group. The NDPP-NextGen group will participate in the adapted NDPP online group class across 12 months, and the control group will get a packet of information about how to be healthy before, during and after pregnancy.

The main goals of the study are:

1. to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMI

2. to assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancy

3. to explore effects of NDPP-NextGen on infant's percentage of fat tissue at birth

All participants will complete up to 4 research visits: baseline, conception, mid-pregnancy, and delivery. These visits will include:

1. Questionnaires about health, diet, activity, smoking, self-confidence, and depression

2. Body size measurements

3. Fasted blood draws

Participants will also be asked to weigh themselves weekly using home scales that are connected to the research database. At the delivery visit, investigators will measure the baby's body size and collect a cord blood sample.

Description:

Intrauterine exposure to maternal overweight/obesity and diabetes transmits risks to offspring, triggering a disease cycle across generations. Over half of US women have overweight or obesity at conception and ~10% of pregnancies are affected by diabetes, exposing nearly 2 million infants each year. Prenatal lifestyle interventions are well-studied, yet begin too late to impact the critical period of conception and early pregnancy. Starting interventions before conception may be key to halting the disease cycle. However, prior research is limited, often lacks offspring outcomes (especially sensitive measures), includes mostly white and affluent participants, and has been challenged to identify women likely to conceive soon. Further research is needed on scalable strategies to improve maternal-child health during preconception and early pregnancy, especially for racial and ethnic minority or low-income women with disparately high prevalence of obesity and diabetes. The National Diabetes Prevention Program (NDPP) is a widely-disseminated lifestyle intervention to reduce weight and glycemia that has untapped potential to improve maternal-child health. From an implementation science perspective, the NDPP has greater potential impact than new interventions that are unlikely to be scaled up, even if efficacious. Denver Health has delivered the NDPP to >1600 adults since 2013, including >350 young women. Preliminary data shows that the NDPP may reduce peri-conceptional risks in diverse, low-income women. While limited engagement by younger women in the NDPP is a concern, strategies to increase engagement (motivational "pre-sessions", remote delivery, and classes specially for young women) are promising. For example, young women attended the 12-month NDPP for 64 days longer after receiving a pre-session, with 2.0 kg/m2 lower preconception BMI and 0.4% lower A1c in early pregnancy, than controls. To plan a preconception trial, the investigators developed a 2-step screening protocol to 1) use electronic health record data (e.g., contraceptive use) to identify women who are more likely to conceive by 24 months (36% vs. 13% for all young women), and 2) outreach to confirm current family planning to expect ≥60% conception, based on preliminary data showing that 73% conceived by 24 months if they endorsed intention to conceive or being sexual active without highly effective contraception. The investigators propose a randomized controlled trial of an enhanced NDPP (NDPP-NextGen) initiated before pregnancy to evaluate effects on maternal-child health. They will recruit 360 women aged 18-39 years with overweight/obesity who are likely to conceive within 24 months. Women will be randomized to NDPP- NextGen or a usual care control group. The specific aims are 1) to assess effects of NDPP-NextGen on peri- conceptional BMI and prenatal glycemia; 2) to assess effects of NDPP-NextGen on gestational weight gain and behavioral outcomes in pregnancy; and 3) to explore effects of NDPP-NextGen on neonatal adiposity and explanatory mechanisms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 403
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Established patient at Denver Health or Atrium Health Wake Forest Baptist

• Biologically female (inclusive of all gender identities)

• Aged 18-39 years

• English- or Spanish-speaking

• BMI =25 kg/m2 (=23 kg/m2 if Asian race)

• Activities that lead to pregnancy in past 3 months

• Interested in pregnancy within 24 months, including:

1. High interest (actively trying to conceive)

2. General interest (not actively trying but wanting to become pregnant in the foreseeable future)

3. Neutral interest (not planning pregnancy or using contraception for religious reasons)

Exclusion Criteria:

• Currently pregnant

• Non-gestational diabetes (type 1, type 2)

• Long-acting contraceptives (intrauterine device, implant, injection) with plans to continue for >1 year (barrier & short-acting hormonal contraception permitted given ease of discontinuing to facilitate pregnancy)

• Medical procedures (e.g., tubal ligation, hysterectomy) or conditions that impede pregnancy (e.g., polycystic ovarian syndrome)

• Documented infertility or unsuccessfully trying to conceive for =12 months

• Prior participation in the NDPP

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight or Obesity

Intervention

Behavioral:
• NDPP-NextGen
NDPP-NextGen will incorporate content on preconception/prenatal health into standard NDPP. Participants will be encouraged to make sustainable improvements in diet and activity, but without pre-set goals to better accommodate diverse, low-income populations. Upon pregnancy, recommendations will adjust to support appropriate GWG, breastfeeding, and postpartum weight loss. We will provide education on diet and activity during pregnancy/postpartum, including sufficient energy intake and exercise safety to support the growing fetus. NDPP-NextGen will include 3 strategies to better engage young women. (1) "Pre-sessions" to increase knowledge of diabetes risks, self-efficacy, and readiness to change using motivational interviewing techniques. (2) Delivering classes remotely (via phone- and video-conference) to facilitate participation regardless of inclement weather, dependent care, illness, transportation, etc. (3) Offering classes specially for young women to increase personal relevance.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peri-conceptional BMI	BMI at conception will be collected with cellular-enabled scales (BodyTrace®) that facilitate weekly at-home measurement to obtain weight closer to conception. Scales automatically transfer weights to a HIPAA-compliant database that is accessible only by the research team. Research staff will monitor for =1 transmitted weight each week, and provide prompts and assistance as needed. Investigators will average the two weights from before/after estimated date of conception to calculate approximate peri-conceptional BMI.	Scale data will be pulled at 6-8 weeks gestation
Other	Rate and timing of gestational weight gain (GWG)	Primary method of collection will be through the use of home cellular scale weights. We will also abstract all weights from prenatal medical records as a secondary method to assess GWG. GWG will be analyzed as the difference from conception to delivery and gain within each trimester, adjusting for BMI at conception. We will also analyze GWG trajectories using linear mixed models with repeated measures drawn from the home scales and/or prenatal clinical weights. We will then classify women as having inadequate, appropriate, or excessive GWG based on BMI category, and analyze using logistic regression, again adjusting for BMI at conception.	Scale data will be pulled weekly from time of conception up to delivery
Other	A1C in early pregnancy	Fasted blood draw	6-8 weeks gestation
Other	Glycemic status in early pregnancy	Fasted blood draw to classify as normoglycemia, pre-diabetes, or type 2 diabetes at conception per American Diabetes Association definitions	6-8 weeks gestation
Other	Rate of gestational diabetes (GDM) in mid-pregnancy	Abstracted from medical records	28-32 weeks gestation
Other	Diet quality	Diet will be assessed with 24-hour dietary recalls using the Automated Self-Administered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars).	Baseline
Other	Diet quality	Diet will be assessed with 24-hour dietary recalls using the Automated Self-Administered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars).	6-8 weeks gestation
Other	Diet quality	Diet will be assessed with 24-hour dietary recalls using the Automated Self-Administered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars).	28-32 weeks gestation
Other	Physical Activity	Assessed using the Pregnancy Physical Activity Questionnaire (PPAQ), while adjusting metabolic task equivalents for pregnancy. Investigators will calculate average activity intensity (sedentary to vigorous) and type (household, occupational, exercise, transportation) over the past 3 months at each collection point. Physical activity outcomes include daily minutes of sedentary, light, moderate, vigorous, household, occupational, exercise, transportation activity.	Baseline
Other	Physical Activity	Assessed using the Pregnancy Physical Activity Questionnaire (PPAQ), while adjusting metabolic task equivalents for pregnancy. Investigators will calculate average activity intensity (sedentary to vigorous) and type (household, occupational, exercise, transportation) over the past 3 months at each collection point. Physical activity outcomes include daily minutes of sedentary, light, moderate, vigorous, household, occupational, exercise, transportation activity.	6-8 weeks gestation
Other	Physical Activity	Assessed using the Pregnancy Physical Activity Questionnaire (PPAQ), while adjusting metabolic task equivalents for pregnancy. Investigators will calculate average activity intensity (sedentary to vigorous) and type (household, occupational, exercise, transportation) over the past 3 months at each collection point. Physical activity outcomes include daily minutes of sedentary, light, moderate, vigorous, household, occupational, exercise, transportation activity.	28-32 weeks gestation
Other	Smoking frequency	Participants will be asked about lifetime and recent (past 6 months) usage of cigarette and marijuana. Smoking outcomes include any smoking in pregnancy (binary) and number of cigarettes (total, trimester-specific).	Baseline
Other	Smoking frequency	Participants will be asked about lifetime and recent (past 6 months) usage of cigarette and marijuana. Smoking outcomes include any smoking in pregnancy (binary) and number of cigarettes (total, trimester-specific).	6-8 weeks gestation
Other	Smoking frequency	Participants will be asked about lifetime and recent (past 6 months) usage of cigarette and marijuana. Smoking outcomes include any smoking in pregnancy (binary) and number of cigarettes (total, trimester-specific).	28-32 weeks gestation
Other	Weight management self-efficacy	Assessed with the Weight Efficacy Lifestyle Questionnaire-Short Form (WEL-SF) on current confidence with weight management around negative emotions, availability, social pressure, physical discomfort, and positive activities. Weight management self-efficacy is a single score derived from the 8-item short form (range 0-72).	Baseline
Other	Weight management self-efficacy	Assessed with the Weight Efficacy Lifestyle Questionnaire-Short Form (WEL-SF) on current confidence with weight management around negative emotions, availability, social pressure, physical discomfort, and positive activities. Weight management self-efficacy is a single score derived from the 8-item short form (range 0-72).	6-8 weeks gestation
Other	Weight management self-efficacy	Assessed with the Weight Efficacy Lifestyle Questionnaire-Short Form (WEL-SF) on current confidence with weight management around negative emotions, availability, social pressure, physical discomfort, and positive activities. Weight management self-efficacy is a single score derived from the 8-item short form (range 0-72).	28-32 weeks gestation
Other	Rate of miscarriages	Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.	Through study completion, an average of 2 years
Other	Rate of stillbirths	Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.	Through study completion, an average of 2 years
Other	Rate of fetal deaths	Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.	Through study completion, an average of 2 years
Other	Rate of pre-term births	Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.	Through study completion, an average of 2 years
Other	Rate of pregnancy-induced hypertension	Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.	Through study completion, an average of 2 years
Other	Rate of pre-eclampsia	Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.	Through study completion, an average of 2 years
Other	Rate of eclampsia	Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.	Through study completion, an average of 2 years
Other	Rate of cesarean delivery	Adverse maternal outcomes will be abstracted from medical records, and analyzed using logistic regression with consideration of a history of these conditions.	Through study completion, an average of 2 years
Other	Neonatal adiposity	Percent of total mass that is fat mass, as measured by air displacement plethysmography using the PEA POD device	At birth
Other	Maternal adiposity	Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device	Baseline
Other	Maternal adiposity	Percent of total mass that is fat mass, as measured by air displacement plethysmography using the BOD POD device	6-8 weeks gestation
Other	Infant birthweight	Medical records	At birth
Other	Rate of macrosomia	Infant birthweight >4000g. Abstracted from medical records	At birth
Other	Rate of infants classified as large for gestational age (LGA)	Infant birthweight >90th percentile. Abstracted from medical records	At birth
Other	Rate of infants classified as small for gestational age	Infant birthweight <10th percentile. Abstracted from medical records	At birth
Other	Rate of infants with low birthweight	Infant birthweight <2500g. Abstracted from medical records	At birth
Other	Instances of fetal growth restriction	Abstracted from medical records	At birth
Other	Rate of infant birth trauma	Abstracted from medical records	At birth
Other	Rate of infant shoulder dystocia	Abstracted from medical records	At birth
Other	Rate of infant intensive care admission	Abstracted from medical records	At birth
Other	Rate of infants with a major congenital anomaly	Abstracted from medical records	At birth
Other	Rate of neonatal hypoglycemia requiring treatment	Abstracted from medical records	At birth
Primary	BMI in early pregnancy	Height and weight will be measured and combined to report BMI at the post-conception research visit occurring at 6-8 weeks gestation.	6-8 weeks gestation
Secondary	Glycemia in early pregnancy	Fasting glucose	6-8 weeks gestation