Evaluation of Three New Strategies to Fight Obesity in Families

This study has been completed.
Sponsor:
Information provided by:
University of Magdeburg
ClinicalTrials.gov Identifier:
NCT00769756
First received: October 8, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

Context: Endeavours to reduce overweight by calorie-restriction diets are often neither sufficient nor sustained. The growing obesity epidemic demands additional measures to enhance and sustain weight loss.

Objective: To evaluate three alternative weight-loss measures on top of a calorie-restriction diet.

Design, Setting, and Participants: Six-month randomized and controlled trial using a three-factorial design. The participants were 110 families with 142 obese parents and their 119 obese children.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Evaluation of Three New Strategies to Fight Obesity in Families

Resource links provided by NLM:


Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • In the parents the outcome variable at 6 months was the relative weight loss. In children, because of their body growth, the outcome variable was the age-adjusted BMI standard deviation score (BMI-SDS). [ Time Frame: six and twelve month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effects of the different combinations of the additional strategies to reduce weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood samples


Enrollment: 261
Study Start Date: April 2006
Study Completion Date: December 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
2

Financial incentive

For the parents the financial incentive was 5 euros for every kilogram of weight-loss. For children the weight loss was calculated differently, taking into account the individual need of each child to lose weight. Children with a body mass index between the 90th and 97th age-adjusted BMI-percentile were asked to maintain their weight, and were paid in dependence on how well they managed to achieve this goal. Children with age-adjusted BMI-percentiles between 97 and 99, or above the 99th age-adjusted BMI-percentile received 5 euros per weight losses of respectively 500 g or 1 kg.

1
The telemedical equipment consisted of a weighing scale for each family, an accelerometer for each participant, and a Homebox for each family which received the data from the scale and the accelerometers via bluetooth and transfered them via a telephone link to a server in Munich.
3
The basic diet for all participants was supported by a list giving the calorie contents of a large variety of food-stuffs. The dual diet group received a second list giving the glycemic index (GI) for a large variety of carbohy-drates. Emphasis was placed on a preference for low-GI carbohydrates but not on avoidance of carbohydrates as required by the Atkins diet.

Detailed Description:

Intervention: All families kept to a calorie-restriction diet and were assigned at random to one or more of three additional weight-loss strategies: (1) a diet on top of calorie-restriction with preference for carbohydrates having a low glycemic index (dual diet), (2) financial incentive, and (3) continuous telemetric control of weight and physical activity (telemonitoring). The design made it possible to determine the effect of each single measure: financial incentive vs. no financial incentive (54 vs.56 families), calorie-restriction vs. dual diet (53 vs. 57 fami-lies) and telemonitoring vs. no telemonitoring (19 vs. 91 families). The design also allowed an assessment of the effects of combinations of the additional measures, each adapted for possible effects of the other factors.

Main Outcome In the parents the outcome variable at 6 months was the relative weight loss. In children, be-cause of their body growth, the outcome variable was the age-adjusted BMI standard deviation score (BMI-SDS). Analysis was done by three-factorial ANOVA and by a one-factorial ANOVA with the included Dunnett test as a post-hoc comparison, to distinguish between the effects of the different combinations of the additional strategies.

  Eligibility

Ages Eligible for Study:   6 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The participating families were recruited by means of newspaper advertisements in the area around the German city of Magdeburg. The children had to be older than 7 years to ensure that they were able to read, and younger than 13 to minimize interferences due to puberty. 177 families responded by telephone and received a letter de-scribing the aim and character of the study. 110 families then decided to participate and were invited to the first of four meetings with intervals of one week between successive meetings.

Criteria

Inclusion Criteria:

  • BMI > 30 kg/m2

Exclusion Criteria:

  • disease of kidney or liver
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769756

Locations
Germany
University Otto-von-Guericke
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
Investigators
Principal Investigator: Claus Luley, MD University Magdeburg, Germany
  More Information

No publications provided

Responsible Party: Prof. Dr. Claus Luley, MD, Institut of Clinical Chemistry, University Magdeburg
ClinicalTrials.gov Identifier: NCT00769756     History of Changes
Other Study ID Numbers: MD 22/06
Study First Received: October 8, 2008
Last Updated: October 8, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by University of Magdeburg:
Different Strategies to Fight Obesity in Families

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014