Early Prevention of Childhood Obesity: an Active Pregnancy
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Madrid、スペイン、28040
- 募集
- Universidad Politécnica de Madrid
-
コンタクト：
- María Perales Santaella, PhD student
- 電話番号：913364081
- メール：m.perales.santaella@gmail.com
-
コンタクト：
- Ruben Barakat, PhD
- 電話番号：913364120
- メール：barakatruben@gmail.com
-
-
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:
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Torrejón, hospital Universitario de Puerta de Hierro and Hospital Universitario Severo Ochoa (Madrid).
Exclusion Criteria:
- Multiparity
- Obstetrician complications
- Being interested in the study after 16 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
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：防止
- 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 |
|---|---|
|
介入なし：コントロール
座りっぱなしの妊婦
|
|
|
実験的：Exercise group
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate |
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate |
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 |
|---|---|---|
|
Body mass index of the offsprings
時間枠：0-24 postpartum months
|
Body mass index was measured several times from 0 to 24 months
|
0-24 postpartum months
|
|
Fetus body composition
時間枠：0-24 postpartum months
|
Fetus body composition (percentage of fat) was measured several times from 0 to 24 months
|
0-24 postpartum months
|
|
Change from baseline in Maternal gestational weight gain
時間枠：40-42 weeks of gestation
|
Maternal weight gain during pregnancy
|
40-42 weeks of gestation
|
|
Changes in Baby motor development
時間枠：0-24 postpartum months
|
Baby motor development was measured after delivery
|
0-24 postpartum months
|
|
Recovery time to pre-gestational weight
時間枠：6-12 postpartum months
|
The time needed to recovery the pre-gestational weight was assessed.
|
6-12 postpartum months
|
|
Glycemia level of the offsprings
時間枠：0-24 postpartum months
|
Glycemia level of the offsprings was measured until 24 months
|
0-24 postpartum months
|
|
Postpartum depression
時間枠：0-12 postpartum months
|
The level of maternal depression was measured after delivery
|
0-12 postpartum months
|
|
Change from baseline in Body image satisfaction
時間枠：up to 36 weeks
|
Body image satisfaction was measured during and after pregnancy
|
up to 36 weeks
|
|
Changes from baseline in maternal quality of life
時間枠：up to 36 weeks
|
Maternal quality of life was measured during and after pregnancy
|
up to 36 weeks
|
|
Placenta measurements
時間枠：At delivery
|
Placenta measurements were collected at labor
|
At delivery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maternal outcomes
時間枠：At delivery
|
Type of labor, stage of labor and some other maternal variables were measured at delivery
|
At delivery
|
|
Control of physical activity
時間枠：up to 10 weeks
|
Control the level of physical activity during and after pregnancy
|
up to 10 weeks
|
|
Changes from delivery in Health of the offspring
時間枠：0-24 postpartum months
|
Health of the baby included the measurement of other variables such as blood pressure and cholesterol of the offsprings until 24 months
|
0-24 postpartum months
|
|
Fetus outcomes
時間枠：At delivery
|
Fetus outcomes were measured at delivery: Apgar score, PH umbilical cord, size and height of the baby, head circumference
|
At delivery
|
協力者と研究者
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 (予想される)
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。