Mood and Excess Weight Gain in Adolescent Pregnancy

Obesity Clinical Trial

Official title:

Mood and Excess Weight Gain in Adolescent Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086161
• Other study ID #: 14-1505
• Status: Completed
• Phase: N/A
• Start date: November 23, 2015
• Est. completion date: January 17, 2020

Study information

• Verified date: February 2021
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. In this randomized controlled pilot study, the investigators are evaluating the feasibility and acceptability of a relatively brief interpersonal psychotherapy program for reducing excess gestational weight gain during adolescent pregnancy. Compared to treatment-as-usual prenatal care delivered in an adolescent maternity clinic, the investigators will estimate the added benefit of an interpersonal psychotherapy program's effectiveness for reducing excess gestational weight gain, improving maternal postpartum insulin sensitivity, and decreasing maternal and infant adiposity.

Description:

Obesity and its negative health consequences such as type 2 diabetes and heart disease are major public health concerns. Pregnancy is an ideal opportunity to intervene with young women both to reduce their own likelihood of long-term obesity and to potentially lessen their offspring's obesity risk. Interventions to reduce excessive weight gain during adolescent pregnancy may be particularly important. 50-70% of adolescents gain too much weight during pregnancy, and this excess gain significantly increases their risk of high postpartum weight retention and long-term obesity. Depression and stress-which are common in adolescent pregnancy-also may play a role. Pregnant adolescent females, as well as non-pregnant females, who have more frequent feelings of depression or stress are more likely to gain weight too rapidly or to gain too much weight as they grow. In the current project, the investigators seek to develop a program to prevent excess weight gain that will be feasible to administer in the Colorado Adolescent Maternity Program (CAMP) at Children's Hospital Colorado, University of Colorado Denver, Anschutz Medical Campus, and, that will be acceptable to pregnant teens at-risk for gaining too much weight. After a screening assessment, adolescent females (13-19y) will be randomly assigned to participate in either a 6-session interpersonal psychotherapy (IPT) program + usual care or to CAMP usual care only. The IPT program will involve 6 1-hour meetings with a trained facilitator and focus on improving relationships, mood, stress, and eating in response to negative feelings. The investigators will assess participants midway through the program, immediately after the program, and again at a 3-month postpartum follow-up. The investigators will evaluate to what extent adolescent females attend the program, complete at-home practice assignments, and show changes in mood, stress, relationships, eating, and mindfulness before and after IPT participation compared to usual care only. The investigators also will estimate how program participation relates to weight gain during pregnancy and 3-month postpartum maternal weight retention, adiposity, and insulin sensitivity. The investigators also will study the adiposity of adolescents' 3-month-old infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 3 Months to 19 Years

Eligibility

Inclusion Criteria:

• 13-19 years of age and the 3-6 month old infants of these adolescent mothers

• Female

• Pregnant, 12-18 weeks gestation

• Patient in the Colorado Adolescent Maternity Program (CAMP) clinic

Exclusion Criteria:

• Full-syndrome Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment (e.g., conduct disorder, schizophrenia, major depressive disorder with active suicidal ideation)

• Major renal, hepatic, endocrinologic (hyperthyroidism or Cushing syndrome), or pulmonary (other than mild asthma) disorder

• Medication affecting mood or body weight

• Major high-risk pregnancy complication (preeclampsia, gestational diabetes, hypertension, multiple gestation, placenta previa, membrane rupture, incompetent cervix)

• Pre-pregnancy BMI <5th percentile for age and sex

Related Conditions & MeSH terms

• Adolescent Development
• Insulin Resistance
• Insulin Sensitivity
• Interpersonal Relations
• Obesity
• Pregnancy Related
• Stress
• Weight Gain

Intervention

Behavioral:
• Interpersonal Psychotherapy
Six individual 1-hour sessions delivered over the course of pregnancy to address interpersonal problems areas that may lead to emotional eating, physical inactivity, and increased stress during pregnancy, which are drivers of excess weight gain in pregnancy
• Treatment-as-usual
Routine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Colorado State University	Children's Hospital Colorado, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	Rate of recruitment	5-year period
Primary	Acceptability	Program session attendance measured as percentage of total sessions (6) attended	6-9 months
Primary	Acceptability of program	Program acceptability ratings	6-9 months
Secondary	Depressive symptoms	Depressive symptoms measured on the Center for Epidemiologic Studies Depression Scale	12 months (9 months of pregnancy plus 3 months postpartum)
Secondary	Perceived stress	Perceived stress measured on the Perceived Stress Scale	12 months (9 months of pregnancy plus 3 months postpartum)
Secondary	Excess gestational weight gain	Weight gained from first-trimester screening to post-intervention assessment, just prior to delivery	9 months
Secondary	Maternal postpartum insulin sensitivity	Maternal postpartum insulin sensitivity	12 months (9 months of pregnancy plus 3 months postpartum)
Secondary	Maternal postpartum adiposity	Maternal postpartum body fat percentage	12 months (9 months of pregnancy plus 3 months postpartum)
Secondary	Infant adiposity	Infant body fat percentage	Infants: 3 months