Madres Para la Salud (Mothers for Health)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85008
- Maricopa Integrated Health System
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from Baseline Body Fat Percentage at 6 months
時間枠：6 months
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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.
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6 months
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Change from Baseline Body Fat Percentage at 12 months
時間枠：12 Months
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Body fat was measured using bioelectric impedance (BIA), with portable four-terminal BIA measurement system (Tanita Corporation of America, Inc, Arlington Heights, IL).
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12 Months
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Change from Baseline Systemic and fat tissue inflammation at 12 months
時間枠：12 months
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Systemic and fat tissue inflammation was measured through a fat biopsy that was conducted by a trained physician (M.D.)
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12 months
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Change from Baseline in Edinburgh Postnatal Depression Scale at 6 months
時間枠：6 months
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Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
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6 months
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Change from Baseline in Edinburgh Postnatal Depression Scale at 12 months
時間枠：12 months
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Postpartum Depression Symptoms were measured with the Edinburgh Postnatal Depression Scale (EPDS)questionnaire.
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12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 6 months
時間枠：6 months
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Social Support and walking were measured through the MOS Social Support survey and the Social Support and Exercise Survey.
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6 months
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Change from baseline in Medical Outcomes Study (MOS) Social Support Survey at 12 months
時間枠：12 months
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Social Support was measured through the MOS Social Support survey and the Social Support and Exercise Survey.
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12 months
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Change from baseline in Neighborhood Health Questionnaire at 6 months
時間枠：6 months
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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.
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6 months
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Change from baseline in Neighborhood Health Questionnaire at 12 months
時間枠：12 months
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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.
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12 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Relationship between Walking Outcomes and listed Primary Outcomes at 6 months
時間枠：6 months
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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).
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6 months
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Relationship between Walking Outcomes and listed Primary Outcomes at 12 months
時間枠：12 months
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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).
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12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Colleen S Keller, PhD、Arizona State University, College of Nursing and Health Innovation
出版物と役立つリンク
一般刊行物
- Records K, Keller C, Ainsworth B, Permana P. Instrument selection for randomized controlled trials: why this and not that? Contemp Clin Trials. 2012 Jan;33(1):143-50. doi: 10.1016/j.cct.2011.09.006. Epub 2011 Oct 1.
- Keller C, Records K, Ainsworth B, Belyea M, Permana P, Coonrod D, Vega-Lopez S, Nagle-Williams A. Madres para la Salud: design of a theory-based intervention for postpartum Latinas. Contemp Clin Trials. 2011 May;32(3):418-27. doi: 10.1016/j.cct.2011.01.003. Epub 2011 Jan 14.
- Keller C, Todd M, Ainsworth B, Records K, Vega-Lopez S, Permana P, Coonrod D, Nagle Williams A. Overweight, obesity, and neighborhood characteristics among postpartum Latinas. J Obes. 2013;2013:916468. doi: 10.1155/2013/916468. Epub 2013 Feb 6.
- Ainsworth BE, Keller C, Herrmann S, Belyea M, Records K, Nagle-Williams A, Vega-Lopez S, Permana P, Coonrod DV. Physical activity and sedentary behaviors in postpartum Latinas: Madres para la Salud. Med Sci Sports Exerc. 2013 Jul;45(7):1298-306. doi: 10.1249/MSS.0b013e3182863de5.
- Vega-Lopez S, Pignotti GA, Keller C, Todd M, Ainsworth B, Nagle Williams A, Records K, Coonrod D, Permana P. Participation in a Social-Support Physical Activity Intervention Modestly Improves Lipoprotein Cholesterol Distribution Among Postpartum Sedentary Hispanic Women. J Phys Act Health. 2015 Sep;12(9):1289-97. doi: 10.1123/jpah.2014-0245. Epub 2014 Nov 19.
- Keller C, Ainsworth B, Records K, Todd M, Belyea M, Vega-Lopez S, Permana P, Coonrod D, Nagle-Williams A. A comparison of a social support physical activity intervention in weight management among post-partum Latinas. BMC Public Health. 2014 Sep 19;14:971. doi: 10.1186/1471-2458-14-971.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Madres para la Saludの臨床試験
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Vanderbilt UniversityUniversity of Miami; National Institute on Minority Health and Health Disparities (NIMHD); Vanderbilt... と他の協力者完了
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University of California, IrvineNational Heart, Lung, and Blood Institute (NHLBI)募集