Evaluation of Three New Strategies to Fight Obesity in Families

NCT00769756 | Completed

• 1 other identifier: MD 22/06
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Different Strategies to Fight Obesity in Families

Outcome Measures

Primary Outcomes (1)

• 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).

  six and twelve month

Secondary Outcomes (1)

• effects of the different combinations of the additional strategies to reduce weight

  12 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• BMI \> 30 kg/m2

You may not qualify if:

• disease of kidney or liver

Sponsors & Collaborators

• University of Magdeburg: lead

Study Sites (1)

University Otto-von-Guericke

Magdeburg, 39120, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claus Luley, MD

  University Magdeburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: April 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 9, 2008

Record last verified: 2008-10

Locations

DE (1)