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Madres Para la Salud (Mothers for Health)

24. juli 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

177

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85008
        • Maricopa Integrated Health System

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline Body Fat Percentage at 6 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 12 months
Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 6 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relationship between Walking Outcomes and listed Primary Outcomes at 6 months
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Arizona State University

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2010

Primær færdiggørelse (Faktiske)

1. februar 2012

Studieafslutning (Faktiske)

1. marts 2012

Datoer for studieregistrering

Først indsendt

19. juli 2013

Først indsendt, der opfyldte QC-kriterier

24. juli 2013

Først opslået (Skøn)

26. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. juli 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2013

Sidst verificeret

1. juli 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1R01NR010356-01A2 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression, postpartum

Kliniske forsøg med Madres para la Salud

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