- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02200484
Project HERA (Health, Education, and Relationship-building for Adolescents- Moms and Tots) (Project HERA)
9 april 2015 uppdaterad av: University of Massachusetts, Worcester
Helping Ethnically Diverse Teen Moms Prevent Obesity in Their Preschool Children
Specific Aims:
- The primary aims of this study are to conduct formative interviews with teen mothers to inform a targeted adaptation of empirically based weight management and parent training programs for teen mothers for their preschoolers.
- To conduct a small pilot and post-pilot focus group of the feasibility and acceptability of recruitment and retention methods & the intervention.
Study Hypotheses:
Given the small sample size and fact that this is a pilot study, focus will be on estimating effect sizes rather than statistical hypothesis testing. However, the investigators exploratory hypotheses are as follows:
- (a) The adapted intervention will be more feasible compared to the wellness control condition, with a participant retention rate of ≥80% and an average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%; (b) The adapted intervention will be more acceptable compared to the wellness control condition, based on the Consumer Satisfaction Scale and Therapy Assessment Inventory with ≥90% of the participants responding to the item, "In general how satisfied were you with the intervention?" by choosing "unsatisfied" to "very satisfied."
- (a) The adapted intervention will result in greater improvements in child behavior and parent-child connectedness compared to the control condition; (b) the adapted intervention versus wellness control condition will result in greater increases in child and teen mother individual as well as joint physical activity and physically active play and greater reductions in individual and joint teen mother and child sedentary behavior (television viewing) from baseline to post-intervention; (c) the greater teen mother and child fruit and vegetable consumption; and reduced child juice and sugar-sweetened beverage consumption from baseline to post-intervention; (d) the adapted intervention versus wellness control condition will result in smaller increases in child BMI percentile and teen mother BMI from baseline to post-intervention; (e) participants who attend higher numbers of intervention sessions will show greater improvements in target outcomes (child behavior, parent-child connectedness, and teen mother and child physical activity, sedentary behavior and BMI); with participants receiving the adapted intervention versus wellness control showing the greatest dose-based improvements.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
25
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Massachusetts
-
Worcester, Massachusetts, Förenta staterna, 01655
- UMass
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
16 år till 20 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Must be teen moms
- Be between 16 and 20 years of age
Exclusion Criteria:
- Does not have a child between the ages of 6 months and 5 years
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Parent Training/Obesity Prevention
Mother-child dyads randomized to the active intervention in the pilot study will be administered 8 weeks of a combined parenting training and obesity prevention program that was adapted through analysis of formative research interviews with adolescent mothers with feedback from an expert panel of multidisciplinary research team members and community members.
|
|
Aktiv komparator: 8-week Wellness Program (Control)
Participants randomized to control condition during intervention piloting will receive print-based health and wellness materials once weekly for 8-weeks + 2 follow up telephone calls at the beginning and conclusion of the 8-week program.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Study Feasibility
Tidsram: Measured at the beginning of participant recruitment through 8 weeks follow up (end of treatment)
|
Feasibility will be assessed during intervention piloting using process evaluation data to determine the pace of recruitment relative to sample size goals and differences in retention by condition.
Descriptive analyses will determine the % of participants recruited, rate of accrual, attrition rate over time and total, % accepting randomization to treatment, and % compliance with study protocols (as measured by number of sessions attended, number who complete homework, etc…).
Due to the small sample size in the current study, the intervention will be considered feasible if the retention rate is ≥ 80% and if the average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%.
The post pilot focus group will probe participants about their perspective on methods used to recruitment them into the study, including advertisements, incentives, location etc...
|
Measured at the beginning of participant recruitment through 8 weeks follow up (end of treatment)
|
Study Acceptability
Tidsram: 8-weeks follow up (end of treatment)
|
We will assess study acceptability via maternal completion of customer satisfaction questionnaires at the end of treatment (8 weeks follow up) for participants randomized (n=46) during intervention piloting to the adapted intervention (combined parenting/obesity prevention program) versus control condition (wellness program).
We will invite a subsample of n=8 adolescent mothers to participate in the post-pilot focus group to further assess study acceptability and probe these participants on the likes and dislikes for the program, and recruitment methods.
|
8-weeks follow up (end of treatment)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Child Problem Behavior
Tidsram: Baseline, Each week for 8 weeks during active treatment, and 8-weeks follow up (end of treatment)
|
We will assess for changes in child problem behavior via maternal completion of child behavior questionnaires administered at baseline, once weekly for eight weeks during active intervention, and at 8 weeks end of treatment (follow up) for participants randomized (n= 46) to the intervention arm (parenting/combined obesity prevention program) versus control (wellness condition).
|
Baseline, Each week for 8 weeks during active treatment, and 8-weeks follow up (end of treatment)
|
Change in Child Physical Activity/Sedentary Behavior
Tidsram: Baseline, 8-weeks follow up (end of treatment)
|
Child physical activity and sedentary behavior will be measured via maternal completion of questionnaires administered at baseline and 8 weeks follow up to assess for changes in these outcomes across participants randomized during intervention piloting (n=46) to the intervention condition (combined parenting/obesity prevention program) versus control condition (wellness program).
Child physical activity and sedentary behavior will also be assessed via a home audit of the home physical activity/sedentary behavior environment completed by the research assistant at baseline and 8-weeks follow up (end of treatment)
|
Baseline, 8-weeks follow up (end of treatment)
|
Change in Child fruit, Vegetable, Junk, Fat and Fast food Intake (Child Nutritional Behavior)
Tidsram: Baseline, 8-weeks follow up (end of treatment)
|
Child nutritional behavior will be measured via maternal completion of questionnaires administered at baseline and 8 weeks follow up to assess for changes in these outcomes across participants randomized during intervention piloting (n=46) to the adapted intervention condition (combined parenting/obesity prevention program) versus control condition (wellness program).
Child nutritional behavior will also be assessed via a home audit completed by the research assistant at baseline and 8-weeks follow up (end of treatment).
|
Baseline, 8-weeks follow up (end of treatment)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Child Weight Status (BMI percentile)
Tidsram: Baseline, 8-weeks follow up (end of treatment)
|
We will measure child height and weight at baseline and 8-weeks follow up (end of treatment) to calculate child BMI percentile to assess for changes in BMI percentile for participants randomized during intervention piloting (n=46) to the adapted intervention condition (combined parenting/obesity prevention program) compared to those in the control condition (wellness program).
|
Baseline, 8-weeks follow up (end of treatment)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2013
Primärt slutförande (Faktisk)
1 september 2014
Avslutad studie (Faktisk)
1 september 2014
Studieregistreringsdatum
Först inskickad
12 juli 2014
Först inskickad som uppfyllde QC-kriterierna
23 juli 2014
Första postat (Uppskatta)
25 juli 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
10 april 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 april 2015
Senast verifierad
1 april 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14864
- R21HL114083 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Förebyggande av fetma
-
The Policy & Research GroupDepartment of Health and Human ServicesRekrytering
-
The Policy & Research GroupDepartment of Health and Human Services; Mathematica Policy Research, Inc.Aktiv, inte rekryterandePrevention av tonårsgraviditetFörenta staterna
-
The Policy & Research GroupThe Office of Adolescent Health, HHSAvslutadPrevention av tonårsgraviditet
-
The Policy & Research GroupDepartment of Health and Human ServicesAvslutadPrevention av tonårsgraviditet
-
University of Colorado, DenverAvslutadPrevention av tonårsgraviditetFörenta staterna
-
The Policy & Research GroupDepartment of Health and Human ServicesAvslutad
-
University of New MexicoDepartment of Health and Human ServicesAvslutadPrevention av tonårsgraviditetFörenta staterna
-
Mathematica Policy Research, Inc.Office of Population Affairs; California Department of Public Health, MCAHAvslutadPrevention av tonårsgraviditetFörenta staterna
-
The Policy & Research GroupDepartment of Health and Human ServicesAvslutadPrevention av tonårsgraviditet
-
Insel Gruppe AG, University Hospital BernUniversity of BernRekrytering
Kliniska prövningar på Combined parent training and obesity prevention program
-
Microclinic InternationalHarvard School of Public Health (HSPH); Qatar University; Qatar Foundation; Qatar Diabetes Association och andra samarbetspartnersAvslutadHypertoni | Övervikt och fetma | Diabetes mellitus, typ II | Beteende livsstilsförändring | Social förändringQatar
-
Fundació Sant Joan de DéuHospital Universitari Vall d'Hebron Research Institute; Fundació La Marató... och andra samarbetspartnersRekryteringFöräldraskap | Genetiskt syndrom | Språkutveckling | Autism eller autistiska dragSpanien
-
Children's Hospital Los AngelesRobert Wood Johnson FoundationRekrytering
-
Massachusetts General HospitalAvslutadPåfrestning | Paroxysmalt förmaksflimmerFörenta staterna
-
Virginia Polytechnic Institute and State UniversityCarilion Clinic; Thomas Jefferson University; Drexel University; Mazzoni Health... och andra samarbetspartnersAktiv, inte rekryterandeSjälvmord | Engagemang, patientFörenta staterna
-
Université de SherbrookeCanadian Institutes of Health Research (CIHR)Rekrytering
-
University of Texas at AustinNational Institute of Nursing Research (NINR)Rekrytering