ObesityNCT00769756
Evaluation of Three New Strategies to Fight Obesity in Families
An observational study of Obesity, run by University of Magdeburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 261 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2006to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- BMI > 30 kg/m2
Who cannot join
- disease of kidney or liver
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Different Strategies to Fight Obesity in Families
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: six and twelve month
Secondary outcomes (1)
effects of the different combinations of the additional strategies to reduce weight
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startApr 2006
- Primary completionApr 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Investigators
- Claus Luley, MD, Principal investigator, University Magdeburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769756
- Sponsor's protocol ID
- MD 22/06
- Status last verified
- Oct 2008
- First submitted
- 8 Oct 2008
- Last updated
- 9 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three New Strategies to Fight Obesity in Families
- ClinicalTrials.gov ID
- NCT00769756
- Acronym / sponsor ID
- MD 22/06
- Conditions
- Obesity
- Keywords
- Different Strategies to Fight Obesity in Families
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- BMI > 30 kg/m2
Key exclusion criteria (1 listed)
- disease of kidney or liver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
effects of the different combinations of the additional strategies to reduce weight
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Luley, MD principal investigator
University Magdeburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2008.