- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02448563
Reducing Obesity in Underserved Postpartum African American Women (RENEW)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The investigators proposal adapts The Diabetes Prevention Program (DPP) 16 session core curriculum to our 8 session model and in addition uses the cultural tailoring techniques of the DPP to address the needs of our AA population in several ways: 1) The reference materials and lesson handouts include information about the types of foods and cooking methods used by an AA culture (see Other Study Documents); 2) Topics are selected for group classes that are most appropriate for our participants such as Hip Hop or Salsa dancing for physical activity.
Participants will be randomized during the early postpartum period to either usual care or intervention. Usual care participants will be offered the weight management standard of care which is one visit with a dietitian in the Nutrition and Weight Management Center. Intervention participants will be assigned a Birth Sister for the postpartum period. They will also attend 8 weekly sessions for the weight loss program. All participants will complete study assessment visits at 6 weeks postpartum and 15 weeks postpartum.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Pre-Natal:
- BMI greater than or equal to 25
- Ready to change (classified as answering yes to: Are you seriously considering trying to lose weight to reach your goal in the next 6 months?)
- English-speaking
Post-partum:
- Live birth (based on medical record review)
Exclusion Criteria:
Pre-Natal:
- Signs of moderate to severe depression based on the Patient Health Questionnaire-9 (PHQ-9)
- Previous enrollment in the Birth Sister's program prior to the study
Post-partum:
- Signs of moderate to severe post-partum depression based on the Edinburgh Postnatal Depression Scale (EPDS)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Intervention
Weekly, in-person, support groups providing nutrition and physical activity education
|
Eight weekly in-person groups
|
Nessun intervento: Control
Standard of care - one counseling visit with a study dietitian
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)
Lasso di tempo: Weekly up to 8 weeks
|
Weekly up to 8 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline Weight to 8 Weeks
Lasso di tempo: Baseline and 8 weeks
|
Baseline and 8 weeks
|
|
Participant Satisfaction as Measured by Questionnaire and Exit Interview
Lasso di tempo: 8 weeks
|
8 weeks
|
|
Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire
Lasso di tempo: Baseline and 8 weeks
|
Items were rated on a 5 point scale (1 strongly disagree, 2 disagree, 3 neutral or not applicable, 4 agree, 5 strongly agree).
We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree).
What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score).
|
Baseline and 8 weeks
|
Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire
Lasso di tempo: Baseline and 8 weeks
|
The Multidimensional Body Relations Questionnaire (MBSRQ-AS) includes the following subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale (BASS).
We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree).
What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score).
Scale ranges from 1-5 (1=definitely disagree, 2=mostly disagree, 3=neither agree nor disagree, 4=mostly agree, 5=definitely agree) with higher scores reflecting better outcome.
A positive value shows improvement in that subscale over time.
|
Baseline and 8 weeks
|
Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale
Lasso di tempo: Baseline and 8 weeks
|
Activity indices were created for each domain of activity (household/caregiving, occupational, active living, sports/exercise) by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5. We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree).
What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at Baseline from that measured at 8 weeks (difference = 8 weeks score - baseline score).
|
Baseline and 8 weeks
|
Waist Circumference at 8 Weeks
Lasso di tempo: 8 weeks
|
8 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Caroline M. Apovian, MD, Professor of Medicine and Pediatrics
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- H-28272
- R21HD061311 (Sovvenzione/contratto NIH degli Stati Uniti)
- U54TR001012 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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