Obesity prevention through familiy based intervention combining physical activity and nutrition counselling

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00007702
• Date of registration: 10/08/2016
• Prospective Registration: No
• Primary sponsor: Marga und Walter Boll-Stiftung
• Public title: Obesity prevention through familiy based intervention combining physical activity and nutrition counselling
• Scientific title: Obesity prevention through familiy based intervention combining physical activity and nutrition counselling - ADEBAR
• Date of first enrolment: 21/06/2016
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00007702
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose: prevention
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Nina Ferrari
• Affiliation: Kölner Zentrum für Prävention im Kindes- und Jugendalter am Herzzentrum der Uniklinik Köln

• Name: Nina Ferrari
• Affiliation: Kölner Zentrum für Prävention im Kindes- und Jugendalter am Herzzentrum der Uniklinik Köln

Key inclusion & exclusion criteria

Inclusion criteria: female, pregnant (<10 week of gestation), BMI>25 kg/m2, ability to speak german, no contraindication for physical activity during pregnancy accroding to ACOG 2015, no drug use which influences body weight, previously inactiv, written consent for participation and blood collection
Exclusion criteria: <18 years of age, >10. week of gestation, multiple pregnancy, not speaking german sufficiently, contraindication for physical activity during pregnancy according to ACOG 2015, drug use which influences body weight

Age minimum: 18 Years
Age maximum: None
Gender: Female

Health Condition(s) or Problem(s) studied

E66.8

E66.8

Other obesity

Intervention(s)

Group 1: intervention:
The intervention is a combination of specific physical activity training (46 units, each 90 minutes) and nutrition counselling (6 units, each 60 minutes) over a period of 8 months (9 weeks of gestation till 38 weeks of gestation):

physical activity training (beginning at 13 weeks of gestation) consist of aerobic exercise (walking) once a week and strenght training (elastic bands) once a week.
Every session will consist of 10 minutes measuring resting blood pressure before beginning, 10-15 minutes gradually warm-up and 10-15 minutes cool-down including low intensity calisthenics, relaxation and stretching (avoiding muscle pain) of most muscle groups (upper and lower limbs, shoulder and trunk) and 10 minutes pelvic floor exercise as described and recommended by the Canadian Society for Exercise Physiology (CSEP 2015). The main part of the session will last 40 minutes. Depending on women’s condition, the main part can be split up in two to three parts of 20 or 15 minutes respectively, with a little break between the parts to avoid physical overload. The duration of the parts may be gradually increased, as intervention progress.
Aerobic exercise sessions will consist of walking. Each woman will wear a portable heart rate monitor and heart rate will be monitored throughout every session to confirm the heart rate recommended by Davenport et al. Furthermore, the talk test will be used to ensure that exercise takes place at a comfortable intensity.
Strength training will consist of exercises targeting major muscles groups in the upper body, trunk and lower body by using resistance bands. In total, the participants will practice 8-10 muscular strength exercises with 12-15 repetitions per exercise for two to three sets. Workload and exercises will be docu

Primary Outcome(s)

Rapid weight gain during the first month of life seems to be a predicator of overweight and obesity in adulthood. Therefore, primary outcome of this study is the BMI of the child after two years, assessed by German percentile (Kromeyer-Hauschild et al. 2001).childrens BMI after two years, calculated by kg/m2 and classified according to German percentiles for children (Kromeyer-Hauschild et al. 2001)

According to Robert-Koch-Institute, normal weight gain (50th percentile) after subtraction of birth weight is nine kilogram at the age of 24 month. BMI (body weight divided by the square of height in meters) shows a difference of 1 kg/m2 at this time point (50th percentile). Therefore, a difference of 1 kg/m2 at the age of two years between intervention and control group will be assumed.

Secondary Outcome(s)

Secondary outcomes will be assessed during pregnancy and post partum and will include:
- Course of pregnancy (weight gain according to IOM recommendation, avoidance of pregnancy-induced diseases and comorbidities, mode of delivery)
- Anthropometric data and health status of new-born (birth weight, length, head circumference, pH Value, Apgar score)
- Fetal biomarker of cord blood (insulin, leptin, adiponectin, resistin, BDNF, TNF alpha, IL-6)
- Maternal biomarker (insulin, leptin, adiponectin, resistin, BDNF, TNF alpha, IL-6) during and after pregnancy - 8th, 14th, 24th, 36th week of gestation and after intervention (labor, 8 weeks post partum, 12 month post partum, 24 month postpartum).
- Paternal biomarker (insulin, leptin, adiponectin, resistin, BDNF, TNF alpha, IL-6) - 8th week of women’s gestation and after intervention (8 weeks post partum, 24 month post partum)
- Child development (age appropriate development of fine and gross motor skills, communication, personal-social skills unsing ASQ-3) at 6 month, 12 month, 18 month, 24 month

Source(s) of Monetary Support

Deutsche Sporthochschule Köln, Institut für Bewegungs- und Neurowissenschaft/Abt. III

Marga und Walter Boll-Stiftung

Ethics review

Status: Approved
Approval date: 29/07/2015
Contact:

[e-mail]

Ethik-Kommission Medizinische Fakultät Bonn

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00007702#studyResults