Clinical trial NCT03086161: Mood and Excess Weight Gain in Adolescent Pregnancy
Official title: Mood and Excess Weight Gain in Adolescent Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Adolescent Development
Pregnancy Related
Insulin Sensitivity
Interpersonal Relations
Stress
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: Children's Hospital Colorado
First posted: 2017-03-22
Enrollment: 37
Sex: FEMALE
Minimum age (years): 3
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: 5-year period
measure: Acceptability
timeFrame: 6-9 months
measure: Acceptability of program
timeFrame: 6-9 months
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 12 months (9 months of pregnancy plus 3 months postpartum)
measure: Perceived stress
timeFrame: 12 months (9 months of pregnancy plus 3 months postpartum)
measure: Excess gestational weight gain
timeFrame: 9 months
measure: Maternal postpartum insulin sensitivity
timeFrame: 12 months (9 months of pregnancy plus 3 months postpartum)
measure: Maternal postpartum adiposity
timeFrame: 12 months (9 months of pregnancy plus 3 months postpartum)
measure: Infant adiposity
timeFrame: Infants: 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Colorado State University
name: Lauren B Shomaker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shomaker LB, Gulley LD, Clark ELM, Hilkin AM, Pivarunas B, Tanofsky-Kraff M, Nadeau KJ, Barbour LA, Scott SM, Sheeder JL. Protocol for a pilot randomized controlled feasibility study of brief interpersonal psychotherapy for addressing social-emotional needs and preventing excess gestational weight gain in adolescents. Pilot Feasibility Stud. 2020 Mar 20;6:39. doi: 10.1186/s40814-020-00578-1. eCollection 2020.