ObesityNCT00198744
Efficacy of Parent-Child Dieting Plans Incorporating Medifast Meal Replacements for Weight Loss
A study testing Medifast FIT! for Kids, standard recommendations for dietary intake in children and both diet plans with and without a parent dieting in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
1. Does a joint parent-child dieting approach, as opposed to an individually-based approach, improve weight loss outcomes? 2. Is a diet which includes Medifast meal replacements as efficacious as a non-supplemented Food Guide Pyramid-based diet (reference diet) in achieving better adherence to the diet, initial weight… Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Medifast FIT! for Kids, standard recommendations for dietary intake in children and both diet plans with and without a parent dieting
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2006
- Phase
- Interventional
- 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 80 males and females between 8 and 15 years of age, who are overweight (> 25kg/m2 or BMI > 95th percentile on BMI-for-age growth charts) and desiring weight loss.
- 40 parents, male or female, with a BMI > 25 kg/m2 and desiring weight loss
- Not using appetite-affecting medications (e.g. Prozac, Ritalin) unless on established and stable doses
- Not using weight loss drugs or herbals (phentermine, sibutramine, orlistat, etc…)
- Willing and able to comply with the protocol requirements
- Child willing and able to give informed consent/assent
Show all 9Show fewer
- Parent or legal guardian willing and able to give informed consent
- Parents must be willing and able to attend all sessions with the child. (One parent or legal guardian is mandatory, however, both are encouraged to attend.)
- Have regular source of health care (e.g. pediatrician) and permission of primary care provider
Who cannot join
- Uncontrolled or unstable use of medications
- Chronic uncontrolled health problems (not including obesity, mild dyslipidemia, hypertension <160/95)
- Bulimia, laxative abuse, substance abuse, alcohol intake > 10 drinks per week, or uncontrolled psychiatric disorder (major depression, bipolar disorder, etc…) as determined at screening
- Breast-feeding or pregnant at screening (determined by serum pregnancy test when applicable)- If a pregnancy occurs during the protocol treatment will end and the pregnancy will be followed to term.
- Child/family distress determined by assessment of family situation at screening
- Food allergies, such as peanuts, to ingredients in Medifast products
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
- Does a joint parent-child dieting approach, as opposed to an individually-based approach, improve weight loss outcomes?
- Is a diet which includes Medifast meal replacements as efficacious as a non-supplemented Food Guide Pyramid-based diet (reference diet) in achieving better adherence to the diet, initial weight loss, reduction in % body fat, and weight maintenance?
- Does regular use of Medifast meal replacements, in conjunction with a Food Guide Pyramid-based diet, result in significantly better compliance, greater dietary satisfaction, dietary quality, and palatability than the reference diet?
- Do children who have lost weight using Medifast meal replacements, as an adjunct to a Food Guide Pyramid-based diet, achieve health benefits compared to baseline values and are these health benefits greater than those obtained following the reference diet?
Read the detailed description
Weight Loss Phase: This phase will take place between week 0 and week 26 (6 months). Participants will be randomly assigned to one of two weight loss treatment groups:
- Medifast meal replacement diet group (3 supplements per day) plus food-based diet
- Reference diet group (Food Guide Pyramid-based diet)
Participants will be further randomly assigned to one of two parent-child approaches:
- Dieting child with one dieting parent
- Dieting child without dieting parent Although it is encouraged to have both parents involved in the child's care, only one parent will be permitted to be dieting as a part of the study along with the child so that we can more cleanly assess the effects of a parent dieting without confounding effects of some families having two parents dieting. Both groups will attend separate biweekly educational lessons during the weight loss phase (same curriculum and teacher). Data collection visits will occur at baseline, week 12, and transition. There are a total of 31 visits for a child participating in this study, and 30.for a parent participating by dieting with their child.
Transition Phase: Transition to a maintenance diet will be individually timed by participant attainment of goal "healthy" weight (BMI≤ 25) or week 26, whichever comes first.
Maintenance Phase: This phase will occur after completion of weight loss or between weeks 27 and 78 (12 months). Groups will attend separate educational lessons (same curriculum and teacher) once every 4 weeks. The Medifast group will reduce supplements to 2 per day with a larger portion of calories from whole foods. The reference diet group will remain on a food-based (no supplements) maintenance diet for the entire 52+ week maintenance period. Data collection visits will occur at weeks 26 and 52.
- Conditions
- Obesity
- Being tested
- Medifast FIT! for Kids, standard recommendations for dietary intake in children, both diet plans with and without a parent dieting
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medifast FIT! for KidsBehavioural
standard recommendations for dietary intake in childrenBehavioural
both diet plans with and without a parent dietingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
BMI
Secondary outcomes (3)
blood changes
body composition
psychometrics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Study completionJun 2006
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.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medifast, Inc.
- Investigators
- Lawrence J Cheskin, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198744
- Sponsor's protocol ID
- MEDI2004-01
- Status last verified
- Jan 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Parent-Child Dieting Plans Incorporating Medifast Meal Replacements for Weight Loss
- ClinicalTrials.gov ID
- NCT00198744
- Acronym / sponsor ID
- MEDI2004-01
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Medifast, Inc.
- Study start
- Jun 2004
- Study completion
- Jun 2006
- First posted
- 20 Sep 2005 (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.
- Does a joint parent-child dieting approach, as opposed to an individually-based approach, improve weight loss outcomes?
- Is a diet which includes Medifast meal replacements as efficacious as a non-supplemented Food Guide Pyramid-based diet (reference diet) in achieving better adherence to the diet, initial weight loss, reduction in % body fat, and weight maintenance?
- Does regular use of Medifast meal replacements, in conjunction with a Food Guide Pyramid-based diet, result in significantly better compliance, greater dietary satisfaction, dietary quality, and palatability than the reference diet?
- Do children who have lost weight using Medifast meal replacements, as an adjunct to a Food Guide Pyramid-based diet, achieve health benefits compared to baseline values and are these health benefits greater than those obtained following the reference diet?
Detailed description
Weight Loss Phase: This phase will take place between week 0 and week 26 (6 months). Participants will be randomly assigned to one of two weight loss treatment groups:
- Medifast meal replacement diet group (3 supplements per day) plus food-based diet
- Reference diet group (Food Guide Pyramid-based diet)
Participants will be further randomly assigned to one of two parent-child approaches:
- Dieting child with one dieting parent
- Dieting child without dieting parent Although it is encouraged to have both parents involved in the child's care, only one parent will be permitted to be dieting as a part of the study along with the child so that we can more cleanly assess the effects of a parent dieting without confounding effects of some families having two parents dieting. Both groups will attend separate biweekly educational lessons during the weight loss phase (same curriculum and teacher). Data collection visits will occur at baseline, week 12, and transition. There are a total of 31 visits for a child participating in this study, and 30.for a parent participating by dieting with their child.
Transition Phase: Transition to a maintenance diet will be individually timed by participant attainment of goal "healthy" weight (BMI≤ 25) or week 26, whichever comes first.
Maintenance Phase: This phase will occur after completion of weight loss or between weeks 27 and 78 (12 months). Groups will attend separate educational lessons (same curriculum and teacher) once every 4 weeks. The Medifast group will reduce supplements to 2 per day with a larger portion of calories from whole foods. The reference diet group will remain on a food-based (no supplements) maintenance diet for the entire 52+ week maintenance period. Data collection visits will occur at weeks 26 and 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 80 males and females between 8 and 15 years of age, who are overweight (> 25kg/m2 or BMI > 95th percentile on BMI-for-age growth charts) and desiring weight loss.
- 40 parents, male or female, with a BMI > 25 kg/m2 and desiring weight loss
- Not using appetite-affecting medications (e.g. Prozac, Ritalin) unless on established and stable doses
- Not using weight loss drugs or herbals (phentermine, sibutramine, orlistat, etc…)
- Willing and able to comply with the protocol requirements
Key exclusion criteria (6 listed)
- Uncontrolled or unstable use of medications
- Chronic uncontrolled health problems (not including obesity, mild dyslipidemia, hypertension <160/95)
- Bulimia, laxative abuse, substance abuse, alcohol intake > 10 drinks per week, or uncontrolled psychiatric disorder (major depression, bipolar disorder, etc…) as determined at screening
- Breast-feeding or pregnant at screening (determined by serum pregnancy test when applicable)- If a pregnancy occurs during the protocol treatment will end and the pregnancy will be followed to term.
- Child/family distress determined by assessment of family situation at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medifast FIT! for Kids | Behavioural | – |
| standard recommendations for dietary intake in children | Behavioural | – |
| both diet plans with and without a parent dieting | Behavioural | – |
Primary outcome
Weight
BMI
3 secondary outcomes
blood changes
body composition
psychometrics
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 20 Sep 2005.
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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.
Lawrence J Cheskin, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medifast FIT! for Kids, standard recommendations for dietary intake in children and both diet plans with and without a parent dieting in people with Obesity, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
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 9 inclusion and 6 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 20 Sep 2005. 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 United States. 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?
Weight. The study lists 2 primary outcomes in all. 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 20 Sep 2005.