Clinical trial NCT05674799: NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
Official title: NDPP-NextGen: A Clinical Trial to Reduce Intergenerational Obesity and Diabetes Risks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight or Obesity
Keywords: Body mass index
Pre-conception
Diabetes Mellitus
Diet
Gestational diabetes
Neonatal adiposity
Maternal and Child Health
Overweight
Obese
Pregnancy
Randomized Control Trial
Weight
adverse maternal outcomes
Diabetes Prevention Program
glucose
gestational weight gain
lifestyle intervention
usual care
remote delivery
young women
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-01-06
Enrollment: 403
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to a 12-month lifestyle intervention promoting healthy diet and activity to reduce body weight (NDPP-NextGen), or usual care
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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
* History of bariatric surgery
* Use of GLP-1s in last year
* Currently receiving clinical obesity treatment

Primary outcomes:
measure: BMI in early pregnancy
timeFrame: 6-8 weeks gestation
Secondary outcomes:
measure: Glycemia in early pregnancy
timeFrame: 6-8 weeks gestation
Other outcomes:
measure: Peri-conceptional BMI
timeFrame: Scale data will be pulled at 6-8 weeks gestation
measure: Rate and timing of gestational weight gain (GWG)
timeFrame: Scale data will be pulled weekly from time of conception up to delivery
measure: A1C in early pregnancy
timeFrame: 6-8 weeks gestation
measure: Glycemic status in early pregnancy
timeFrame: 6-8 weeks gestation
measure: Rate of gestational diabetes (GDM) in mid-pregnancy
timeFrame: 28-32 weeks gestation
measure: Diet quality
timeFrame: Baseline
measure: Diet quality
timeFrame: 6-8 weeks gestation
measure: Diet quality
timeFrame: 28-32 weeks gestation
measure: Physical Activity
timeFrame: Baseline
measure: Physical Activity
timeFrame: 6-8 weeks gestation
measure: Physical Activity
timeFrame: 28-32 weeks gestation
measure: Smoking frequency
timeFrame: Baseline
measure: Smoking frequency
timeFrame: 6-8 weeks gestation
measure: Smoking frequency
timeFrame: 28-32 weeks gestation
measure: Weight management self-efficacy
timeFrame: Baseline
measure: Weight management self-efficacy
timeFrame: 6-8 weeks gestation
measure: Weight management self-efficacy
timeFrame: 28-32 weeks gestation
measure: Rate of miscarriages
timeFrame: Through study completion, an average of 2 years
measure: Rate of stillbirths
timeFrame: Through study completion, an average of 2 years
measure: Rate of fetal deaths
timeFrame: Through study completion, an average of 2 years
measure: Rate of pre-term births
timeFrame: Through study completion, an average of 2 years
measure: Rate of pregnancy-induced hypertension
timeFrame: Through study completion, an average of 2 years
measure: Rate of pre-eclampsia
timeFrame: Through study completion, an average of 2 years
measure: Rate of eclampsia
timeFrame: Through study completion, an average of 2 years
measure: Rate of cesarean delivery
timeFrame: Through study completion, an average of 2 years
measure: Neonatal adiposity
timeFrame: At birth
measure: Maternal adiposity
timeFrame: Baseline
measure: Maternal adiposity
timeFrame: 6-8 weeks gestation
measure: Infant birthweight
timeFrame: At birth
measure: Rate of macrosomia
timeFrame: At birth
measure: Rate of infants classified as large for gestational age (LGA)
timeFrame: At birth
measure: Rate of infants classified as small for gestational age
timeFrame: At birth
measure: Rate of infants with low birthweight
timeFrame: At birth
measure: Instances of fetal growth restriction
timeFrame: At birth
measure: Rate of infant birth trauma
timeFrame: At birth
measure: Rate of infant shoulder dystocia
timeFrame: At birth
measure: Rate of infant intensive care admission
timeFrame: At birth
measure: Rate of infants with a major congenital anomaly
timeFrame: At birth
measure: Rate of neonatal hypoglycemia requiring treatment
timeFrame: At birth
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Katherine Sauder, PhD
role: PRINCIPAL_INVESTIGATOR
References: