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Madres Para la Salud (Mothers for Health)

24. července 2013 aktualizováno: Colleen Keller, Arizona State University

The purpose of "Madres Para la Salud" [Mothers for Their Health] is to see how support and encouragement can help women to make positive changes in their health. This program tested if supportive information, encouragement, and walking as a group would increase physical activity and health benefits, such as weight loss and postpartum depression.

Participants in this study were randomly assigned to one of two groups, a walking or a non-walking group. The walking group met weekly. Participants were given a pedometer to record the number of steps taken daily.

Participants met one time each week with our study staff. Participants walked four other days per week on their own, or with other group members. Participants measurements included body fat, waist, and hip at the beginning of the study, and at 3, 6, 9, and 12 months. The non-walking group received a weekly mailed newsletter about topics such as parenting, infant growth and development, and reproductive health. Non-walking group participants' measurements included body fat, waist, and hip at the beginning of the study and at 6 and 12 months.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Project Summary

The purpose of "Madres para la Salud" (Mothers for Health) was to explore the effectiveness of a culturally specific intervention using walking "bouts" to affect changes in the health of Hispanic women following childbirth. The project will advance our understanding of the relationship between moderate increases in physical activity and consequent body fat loss and decreased postpartum depression symptoms in sedentary Hispanic women during the postpartum period. This was accomplished by having a group of women who participated in supportive information and walking sessions, both alone and with study personnel, and an attention control group who received monthly phone calls to address common postpartum health concerns, but who did not participate in the walking program. Both groups received weekly health-focused newsletters with no content related to the intervention. The women had a random assignment to a group.

Study Aims

The purpose of this social support intervention program was to test the theory-driven Madres para la Salud with Hispanic women by conducting a formative evaluation of the intervention:

Aim 1: Examine the effectiveness of the Madres para la Salud, a theoretically driven social support intervention for reducing the distal outcomes in: (a) body fat; (b) systemic and fat tissue inflammation; and (c) PPD symptoms among postpartum Hispanic women compared with an attention control group, at 6 and 12 months, after controlling for dietary intake.

Aim2: Test whether the theoretical mediators, intermediate outcomes, of social support and walking, and environmental factor moderators, affect changes in body fat; systemic and fat tissue inflammation; and PPD symptoms among postpartum Hispanic women completing the Madres para la Salud intervention compared with an attention control group, at 6 and 12 months, after controlling for dietary intake.

Aim 3: Determine the relationship between the immediate outcome of walking (minutes walked per week) and change in the distal outcomes of: (a) body fat; (b) systemic and fat tissue inflammation; and (c) PPD symptoms.

Typ studie

Intervenční

Zápis (Aktuální)

177

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85008
        • Maricopa Integrated Health System

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 40 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • Hispanic descendent
  • Between 18 and 40 years old
  • At least 6-weeks but less than 6-months post childbirth
  • Sedentary (according to the American College of Sports Medicine)
  • Have the ability to participate in moderate intensity physical activity (according to the Physical Activity Readiness Questionnaire (PAR-Q))

Exclusion Criteria:

  • Pregnant or planning a pregnancy in the next 12 months
  • Have a BMI less than 25 or greater than 35
  • Take anti-depressant medications
  • Take anticoagulants or herbal therapy to thin the blood
  • Participate in regular, strenuous physical activity (exceeding 150 minutes of moderate physical activity per week)
  • Severe musculoskeletal or cardiorespiratory problems that would preclude physical activity
  • Infectious illness
  • Acute inflammation (white blood count outside the normal range of 4.8-10.8 of 1000/mm3)
  • Chronic systemic inflammatory diseases (e.g., rheumatoid arthritis), or other acute illness that may affect systemic inflammation at the time of blood draw and fat tissue biopsy
  • Regularly taking high doses of oral steroid medication (more than typical basal replacement levels)
  • High doses of aspirin (above 1 g/day), or high doses of nonsteroidal anti-inflammatory drugs (e.g., 3-4 times/day)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Madres para la Salud
Participants attended Madres para la Salud sessions in a group, led by a promotora at the Maricopa Medical Center and other community based sites. Sessions consisted of a 30 minute education and social support session where women learned to walk at least 150 minutes a week at a 20 minute-mile pace, and up to 30 minutes of moderate intensity walking with the group. Participants received an Omron pedometer and learned to monitor walking intensity. Participants set and reviewed weekly walking goals at the group sessions and recorded aerobic steps per day. After the 12 week sessions, participants met with the promotora once a week for 40 weeks, in-group, to walk at a moderate intensity for 30 minutes, to download and review pedometer data. Data was collected at baseline, 3, 6, 9 and 12 months.
Behaviorální: Madres para la Salud
Participants attended Madres para la Salud sessions in a group, led by a promotora at the Maricopa Medical Center and other community based sites. Sessions consisted of a 30 minute education and social support session where women learned to walk at least 150 minutes a week at a 20 minute-mile pace, and up to 30 minutes of moderate intensity walking with the group. Participants received a pedometer and learned to monitor their walking intensity. Participants set and reviewed weekly walking goals at the group sessions and recorded aerobic steps per day. After the 12 week sessions, participants met with the promotora once a week for 40 weeks of in-group walking at a moderate intensity for 30 minutes, to download and review pedometer data. Data was collected at baseline, 3, 6, 9 and 12 months.
Žádný zásah: Attention-control
Participants in the attention receive monthly brief telephone calls by research technicians and collection of study data on-site at the Maricopa Medical Center and other community based sites at baseline, 6, and 12 months (T1, T3, T5). The staff did not give advice or support specific to walking, which enabled a valid evaluation of the intervention effect. The content given to the attention-control group did not include the "active ingredients" of the Madres para la Salud intervention. The attention-control group received monthly mailings of health-related information regarding common postpartum or newborn concerns, such as breastfeeding, infant sleep, sibling rivalry, emotional support related to new parenthood, and early childhood development topics.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from Baseline Body Fat Percentage at 6 months
Časové okno: 6 months
Body fat was measured using bioelectric impedance (BIA), with portable four-terminal BIA measurement system (Tanita Corporation of America, Inc, Arlington Heights, IL). Instrument calibration was performed internally prior to each estimate of body composition. Measurement of body composition using BIA analysis followed the method outlined by Ritchie, Miller, and Smiciklas-Wright (Ritchie, Miller, & Smiciklas-Wright, 2005). A subsample of the intervention group had body fat measured with state-of-the-art dual energy x-ray absorptiometry (DEXA) at baseline and 12 months.
6 months
Change from Baseline Body Fat Percentage at 12 months
Časové okno: 12 Months
Body fat was measured using bioelectric impedance (BIA), with portable four-terminal BIA measurement system (Tanita Corporation of America, Inc, Arlington Heights, IL).
12 Months
Change from Baseline Systemic and fat tissue inflammation at 12 months
Časové okno: 12 months
Systemic and fat tissue inflammation was measured through a fat biopsy that was conducted by a trained physician (M.D.)
12 months
Change from Baseline in Edinburgh Postnatal Depression Scale at 6 months
Časové okno: 6 months
Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
6 months
Change from Baseline in Edinburgh Postnatal Depression Scale at 12 months
Časové okno: 12 months
Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
12 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 6 months
Časové okno: 6 months
Social Support and walking were measured through the MOS Social Support survey and the Social Support and Exercise Survey.
6 months
Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 12 months
Časové okno: 12 months
Social Support was measured through the MOS Social Support survey and the Social Support and Exercise Survey.
12 months
Change from baseline in Neighborhood Health Questionnaire at 6 months
Časové okno: 6 months
Environmental Factor Moderators were measured through the Neighborhood Health Questionnaire. This questionnaire includes questions relating to Neighborhood walkability, Aesthetic Quality, Safety, Social Cohesion, Violence, and Activities with neighbors.
6 months
Change from baseline in Neighborhood Health Questionnaire at 12 months
Časové okno: 12 months
Environmental Factor Moderators were measured through the Neighborhood Health Questionnaire. This questionnaire includes questions relating to Neighborhood walkability, Aesthetic Quality, Safety, Social Cohesion, Violence, and Activities with neighbors.
12 months

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Relationship between Walking Outcomes and listed Primary Outcomes at 6 months
Časové okno: 6 months
The relationship between walking outcomes and the previously listed primary outcomes was measured through the change in body fat and postpartum depression symptoms (at Baseline, 6 months, and 12 months), systemic and fat tissue inflammation (at Baseline and 12 months).
6 months
Relationship between Walking Outcomes and listed Primary Outcomes at 12 months
Časové okno: 12 months
The relationship between walking outcomes and the previously listed primary outcomes was measured through the change in body fat and postpartum depression symptoms (at Baseline, 6 months, and 12 months), systemic and fat tissue inflammation (at Baseline and 12 months).
12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Arizona State University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Colleen S Keller, PhD, Arizona State University, College of Nursing and Health Innovation

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2010

Primární dokončení (Aktuální)

1. února 2012

Dokončení studie (Aktuální)

1. března 2012

Termíny zápisu do studia

První předloženo

19. července 2013

První předloženo, které splnilo kritéria kontroly kvality

24. července 2013

První zveřejněno (Odhad)

26. července 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

26. července 2013

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. července 2013

Naposledy ověřeno

1. července 2013

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1R01NR010356-01A2 (Grant/smlouva NIH USA)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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