Emotion-Diet Interactions in Pregnancy (PREDIP)

University of California Irvine (UCI)

Status: Completed

Conditions: Emotional Stress; Postprandial Hyperglycemia; Insulin Sensitivity/Resistance; Pregnancy Related; Glucose Intolerance During Pregnancy; Stress, Psychological

Treatments: Behavioral: Psychosocial stress; Behavioral: Control non-stress

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04430439

R00HD096109 (U.S. NIH Grant/Contract)

20205914

Details and patient eligibility

About

This study will investigate how maternal emotional state following a controlled stress exposure in pregnancy influences blood glucose and insulin levels after eating a standardized meal, and whether the effects of emotional state on blood glucose and insulin is different after eating a healthy meal (low GI) compared to a less healthy meal (high GI).

Full description

Maternal glucose-insulin homeostasis in pregnancy represents one of the most important physiological processes for maternal and child health outcomes. Although maternal diet is a key regulator of this process, its effects vary widely across individuals. Maternal stress could represent a moderator of considerable importance in this regard, yet little is known about the effects of stress on glycemic control in pregnancy and whether the effects of stress may vary as a function of diet quality. This project will investigate the effects of acute psychosocial stress exposure on the postprandial metabolic response to a meal of varying glycemic index (GI) among women with overweight/obesity in mid-pregnancy.

Enrollment: 113 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• English and/or Spanish speaking
• 18-22 week's gestation
• Pre-pregnancy BMI 25.0-39.9 kg/m2
• Singleton, intrauterine pregnancy
• Non-smoker
• Non-diabetic and normal result on a random peripheral blood glucose test at the screening visit (<200 mg/dl)

Exclusion criteria

• Non-fluency in English or Spanish
• BMI <25.0 or ≥40.0 kg/m2
• >22 week's gestation
• multiple pregnancy
• current smoker
• present/prior obstetric conditions (preeclampsia, infections, placental abnormalities, uterine anomalies, congenital malformations, fetal chromosomal abnormalities)
• presence of any conditions that may dysregulate neuroendocrine, metabolic or cardiovascular function, such as diabetes, hepatic, renal, or autoimmune disorders
• current psychiatric disorders or undergoing treatment/taking psychiatric medications
• use of systemic/frequent corticosteroids or thyroid, lipid-lowering or anti-diabetic medications
• gestational diabetes mellitus or raised glucose result detected on the screening visit
• unwilling to eat the standard breakfast meal at each laboratory visit

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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113 participants in 2 patient groups

Psychosocial stress

Experimental group

Description:

Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).

Treatment:

Behavioral: Psychosocial stress

Control non-stress

Active Comparator group

Description:

Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).

Treatment:

Behavioral: Control non-stress