ObesityFOCUSNCT00881478
Family Intervention for Obese Children Using Portion Control Strategy for Weight Control
A study testing Nutrition counseling in people with Obesity, run by University of Calgary at 1 site in Canada.
Trial summary
Obesity in children is a serious disease that is associated with increased mortality and decreased life expectancy. A simple tool used to assist in controlling portions (and therefore calorie intake) at mealtime would be of benefit in promoting weight maintenance and/or loss. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nutrition counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Aug 2014
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 8 years old to 16 years old
- BMI greater than or equal to the 85th percentile for age and gender
Who cannot join
- patients currently taking a weight loss medication
- gastrointestinal disorder
- psychiatric illness under the care of a psychiatrist
- Cushing's syndrome
- hypothalamic or genetic etiology of obesity
- uncontrolled or untreated thyroid disease
Show all 11Show fewer
- current diagnosis of cancer
- history of an eating disorder such as bulimia or anorexia nervosa
- surgery in the past 3 months
- surgery planned in the ensuing 6 months
- any chronic illness that could affect weight status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Intervention for Obese Children Using Portion Control Strategy (F.O.C.U.S.) for Weight Control- A Randomized Controlled Trial
Obesity in children is a serious disease that is associated with increased mortality and decreased life expectancy. A simple tool used to assist in controlling portions (and therefore calorie intake) at mealtime would be of benefit in promoting weight maintenance and/or loss. The purpose of this study is to assess the efficacy of a family intervention using a portion control tool to help control weight in obese children. The investigators hypothesize that the use of portion control tools by the parents and child will result in a greater decrease in the child's BMI over a 6 month period compared with the control group.
Read the detailed description
This study is a randomized controlled trial designed to assess the efficacy of a portion control tool to help improve body mass index in obese children over a 6 months period. This study will also assess whether this weight control strategy results in improvement of blood pressure, waist circumference, and biomarkers of obesity including plasma visfatin, adiponectin, fasting lipid profile and apolipoprotein B, liver function tests and fasting insulin and glucose. Both the intervention and the control group will receive a one hour session of standard dietary counseling from a registered dietician at baseline regarding healthy eating habits, appropriate portion sizes and the Canada Food Guide. The duration of this study will be 6 months. Baseline measurements will be taken at the initial visit and again at 3 months and 6 months. Each participants' height and weight will be measured, and BMI will be calculated. Waist circumference and blood pressure will also be measured. A blood sample will be drawn at baseline and 6 months for a fasting lipid profile, fasting insulin, and glucose levels. Measurement of plasma visfatin and adiponectin levels using ELISA will be carried out.
- Conditions
- Obesity
- Being tested
- Nutrition counseling + portion control tool, Nutrition counseling
- Keywords
- Obesity, Children, Dyslipidemia, Hypertension
- Medical subject headings
- Obesity, Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition counseling + portion control toolOther
Nutrition counseling with registered dietician in addition to teaching about how use of a portion control tool
Nutrition counselingOther
Nutrition counseling with registered dietician
| Study group | Role | What they receive |
|---|---|---|
| Nutrition counselling alone | Active comparator | Nutrition counseling session with registered dietician Receives: Other: Nutrition counseling |
| Nutrition counselling + portion control | Experimental | Nutrition counseling with registered dietician in addition to teaching about use of a portion control tool Receives: Other: Nutrition counseling + portion control tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in age and gender adjusted BMI z-score
Measured: 6 months
Secondary outcomes (7)
Change in age and gender adjusted waist circumference percentile
Measured: 6 months
Change in age and gender adjusted blood pressure percentile
Measured: 6 months
Change in fasting lipid profile
Measured: 6 months
Change in fasting insulin and fasting glucose
Measured: 6 months
Change in plasma visfatin level
Measured: 6 months
Change in plasma adiponectin level
Measured: 6 months
Proportion of children achieving a BMI below the 85th percentile for age and gender
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josephine Ho, University of Calgary
- Investigators
- Josephine Ho, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881478
- Sponsor's protocol ID
- E22161
- Acronym
- FOCUS
- Status last verified
- Oct 2011
- First submitted
- 13 Apr 2009
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Pedersen SD, Kang J, Kline GA. Portion control plate for weight loss in obese patients with type 2 diabetes mellitus: a controlled clinical trial. Arch Intern Med. 2007 Jun 25;167(12):1277-83. doi: 10.1001/archinte.167.12.1277.
PubMed 17592101
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Intervention for Obese Children Using Portion Control Strategy (F.O.C.U.S.) for Weight Control- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00881478
- Acronym / sponsor ID
- FOCUS / E22161
- Conditions
- Obesity
- Keywords
- Obesity, Children, Dyslipidemia, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Apr 2009 (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.
Obesity in children is a serious disease that is associated with increased mortality and decreased life expectancy. A simple tool used to assist in controlling portions (and therefore calorie intake) at mealtime would be of benefit in promoting weight maintenance and/or loss. The purpose of this study is to assess the efficacy of a family intervention using a portion control tool to help control weight in obese children. The investigators hypothesize that the use of portion control tools by the parents and child will result in a greater decrease in the child's BMI over a 6 month period compared with the control group.
Detailed description
This study is a randomized controlled trial designed to assess the efficacy of a portion control tool to help improve body mass index in obese children over a 6 months period. This study will also assess whether this weight control strategy results in improvement of blood pressure, waist circumference, and biomarkers of obesity including plasma visfatin, adiponectin, fasting lipid profile and apolipoprotein B, liver function tests and fasting insulin and glucose. Both the intervention and the control group will receive a one hour session of standard dietary counseling from a registered dietician at baseline regarding healthy eating habits, appropriate portion sizes and the Canada Food Guide. The duration of this study will be 6 months. Baseline measurements will be taken at the initial visit and again at 3 months and 6 months. Each participants' height and weight will be measured, and BMI will be calculated. Waist circumference and blood pressure will also be measured. A blood sample will be drawn at baseline and 6 months for a fasting lipid profile, fasting insulin, and glucose levels. Measurement of plasma visfatin and adiponectin levels using ELISA will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition counselling alone | Active comparator | Other: Nutrition counselingNutrition counseling session with registered dietician |
| Nutrition counselling + portion control | Experimental | Other: Nutrition counseling + portion control toolNutrition counseling with registered dietician in addition to teaching about use of a portion control tool |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 8 years old to 16 years old
- BMI greater than or equal to the 85th percentile for age and gender
Key exclusion criteria (11 listed)
- patients currently taking a weight loss medication
- gastrointestinal disorder
- psychiatric illness under the care of a psychiatrist
- Cushing's syndrome
- hypothalamic or genetic etiology of obesity
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 |
|---|---|---|
| Nutrition counseling + portion control toolNutrition counseling with registered dietician in addition to teaching about how use of a portion control tool | Other | Nutrition counselling + portion control |
| Nutrition counselingNutrition counseling with registered dietician | Other | Nutrition counselling alone |
Primary outcome
Change in age and gender adjusted BMI z-score
Time frame: 6 months
7 secondary outcomes
Change in age and gender adjusted waist circumference percentile
Time frame: 6 months
Change in age and gender adjusted blood pressure percentile
Time frame: 6 months
Change in fasting lipid profile
Time frame: 6 months
Change in fasting insulin and fasting glucose
Time frame: 6 months
Change in plasma visfatin level
Time frame: 6 months
Change in plasma adiponectin level
Time frame: 6 months
Proportion of children achieving a BMI below the 85th percentile for age and gender
Time frame: 6 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 3 Sep 2014.
- Background: PubMed 17592101Pedersen SD, Kang J, Kline GA. Portion control plate for weight loss in obese patients with type 2 diabetes mellitus: a controlled clinical trial. Arch Intern Med. 2007 Jun 25;167(12):1277-83. doi: 10.1001/archinte.167.12.1277.
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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.
Josephine Ho, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition counseling in people with Obesity, run by University of Calgary at 1 site in Canada.
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 2 inclusion and 11 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 3 Sep 2014. 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 Canada. 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?
Change in age and gender adjusted BMI z-score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00881478, which also lists 1 linked publication.
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 3 Sep 2014.