Children's Hospital Colorado
Aurora, Colorado, 80045, United States
NCT Number: NCT03086161
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.
Looking for future studies?
Notify Me3 month–19 year
Female
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Routine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work
Time frame: 5-year period
Rate of recruitment
Time frame: 6-9 months
Program session attendance measured as percentage of total sessions (6) attended
Time frame: 6-9 months
Program acceptability ratings
Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)
Depressive symptoms measured on the Center for Epidemiologic Studies Depression Scale
Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)
Perceived stress measured on the Perceived Stress Scale
Time frame: 9 months
Weight gained from first-trimester screening to post-intervention assessment, just prior to delivery
Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)
Maternal postpartum insulin sensitivity
Time frame: 12 months (9 months of pregnancy plus 3 months postpartum)
Maternal postpartum body fat percentage
Time frame: Infants: 3 months
Infant body fat percentage
Colorado State University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04992299
Adolescent Development, Behavior
Aurora, Colorado, United States
View Trial DetailsNCT05443347
Appetite, Body Weight
Kansas City, Missouri, United States
View Trial DetailsNCT04028921
Body Weight, Glucose Metabolism Disorders
Kansas City, Missouri, United States
View Trial DetailsNCT04114903
Body Weight, Cannabis Use
Boulder, Colorado, United States
View Trial Details