OverweightPhase 1NCT00207519
Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents
A Phase 1 study testing weekly behavioral modification group and liquid meal replacements in people with Overweight and Obesity, run by Boston Medical Center at 1 site in United States.
Trial summary
In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age >85th percentile) a structured meal plan consisting of meal replacements, fruits, vegetables, whole grains, lean protein and dairy products. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- weekly behavioral modification group and liquid meal replacements
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jan 2009
- Phase
- Phase 1
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- BMI >85th% for age and sex
- Weight gain over the last 6 months of >5% than expected on the growth curve
- 12-17 years of age
Who cannot join
- Subjects with intolerance to dairy products (e.g., lactose intolerance) will be excluded from entering into the study.
- Subjects must not have a history of clinically significant cardiac disease, congenital heart disease, any clinically significant abnormal cardiac condition, or be known to have a clinically significantly abnormal ECG. Specifically excluded conditions include coronary artery disease, clinically significant cardiac arrhythmias, and congestive heart failure.
- Subjects must not have a history of anorexia nervosa, untreated hypothyroidism (TSH greater than 4.0 mU/L for a second generation test), malignancy, pathophysiologic or genetic syndromes associated with obesity (i.e., Cushing's syndrome, Turner's syndrome, Prader Willi syndrome), major psychiatric illness such as bi-polar disorder, ADD, major depression, bulimia, schizophrenia, or psychosis.
- Subjects may not participate in any weight management program, except for that in this study, during this pilot. Subjects may not use prescription or over-the-counter (or herbal) weight control medication during the trial.
- Subjects must not have a history of alcohol or drug addiction or substance abuse within the previous 2 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical
Boston, Massachusetts, 02118
About this study
Official title: The Use of Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents: A 12 Week Safety and Efficacy Study
In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age >85th percentile) a structured meal plan consisting of meal replacements, fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and invite at least one parent to the scheduled visits, however, no subject will be eliminated because of lack of parental involvement. In this study, we will conduct behavior modification group sessions using lessons which are structured and patterned after the suggestions documented in the LEARNÒ Program for Weight Control. Diet instruction by a registered dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan will be developed by the dietitian for subjects to follow.
Subjects will return on a weekly basis for behavioral modification groups sessions in conjunction with the liquid meal replacement diet. Blood work and physical examinations will occur pre and post intervention.
Read the detailed description
In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age >85th percentile), a structured meal plan consisting of meal replacements, fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and invite at least one parent to the scheduled visits, however, no subject will be eliminated because of lack of parental involvement. Parents will be encouraged to attend group sessions designed to include behavior modification, nutrition education, physical activity recommendations, and food demonstrations as a means of family support for the subject. In this study, we will conduct behavior modification group sessions using lessons which are structured and patterned after the suggestions documented in the LEARN Program for Weight Control. Diet instruction by a registered dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan will be developed by the dietitian for subjects to follow. Subjects will return for 12 weekly group sessions.
For the purposes of this pilot study, mild hypertension is defined as a systolic blood pressure of >130 but <140 mm Hg and a diastolic blood pressure of >85 but <90 mm Hg. Dyslipidemia will be defined as a total cholesterol of >200 mg/dl, LDL >130 mg/dl, HDL <40 mg/dl for male subjects and <50 mg/dl for female subjects, and triacylglycerol of >150 mg/dl. Insulin resistance/diabetes shall be defined as a fasting glucose of >110 mg/dl.
Calculating Estimated Caloric Need:
Total caloric needs for subjects with a BMI >85th% for age and sex shall be calculated using the Basal Energy Expenditure multiplied by an Activity Factor (for an estimate of total energy requirements), then subtracting 250-500 calories (to achieve a 0.5 to 1 pound weight loss per week). Basal Energy Expenditure will be calculated by using the Harris-Benedict equation as follows:
Females = 655 + 4.4(wt. in lbs) + 4.3(ht. in inches) - 4.7(age in yrs) x AF Males = 66 + 6.2(wt. in lbs) +12.7(ht. in inches) - 6.8(age in yrs) x AF
Activity Factors (AF):
1.1 Restricted Activity 1.2 Sedentary (most commonly used) 1.3 Cardiovascular Activity 3x/wk
Ideal body weight is defined as:
Females = 100 lb for the first 5 ft + 5 lb for each inch over 5 ft Males = 106 lb for the first 5 ft + 6 lb for each inch over 5 ft
Subjects will be prescribed a meal plan consisting of 3 meals and 2 snacks per day. However, 2 of the 3 meals will be replaced with a liquid meal replacement which contains 220 kcal, 10 g. protein, 40 g. carbohydrate, 2.5-3 g. fat, and 5 g. dietary fiber as well as vitamin and mineral fortification. The third meal will be high in fruits, vegetables, whole grains, lean protein (30-45 g/day) and contain 600-900 kcal. Low-calorie snacks, to include additional fruit servings, will be encouraged. The meal replacements will be taken at a time the subject will be most compliant, i.e., if subject is a chronic breakfast skipper, a meal replacement will be added for the breakfast meal. All meal replacements will be provided to the subjects at no cost; subjects will complete an order form at each visit indicating flavor choices of vanilla, chocolate or strawberry for the liquid meal replacements. They will be offered the option of a meal replacement bar versus liquid meal replacement for only one of the meal replacements per day (220 kcal, 8 g. protein, 36 g. carbohydrate, 2 g. dietary fiber). These will be a choice of chocolate peanut or granola/fruit bars.
To identify and encourage dietary compliance, subjects will be provided with a food record and will be instructed to complete 3 food records per week, two week days and one weekend day, and to indicate the time of day and which type of meal replacement was consumed. This indication will be helpful in dietary instruction regarding time of day compliance is best for consuming the meal replacement. Subjects will also be instructed to return any unused meal replacements and labels from consumed meal replacements at their regularly scheduled visits as further identification of compliance to diet. A validated Youth and Adolescent Food Frequency Questionnaire or Adolescents Food Habits Checklist will be obtained at the beginning and end of the pilot study. Blood work and a physical exam will be performed pre and post intervention.
- Conditions
- Overweight, Obesity
- Being tested
- weekly behavioral modification group, liquid meal replacements
- Keywords
- overweight, obesity, adolescent
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weekly behavioral modification groupBehavioural
liquid meal replacementsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome measures include for efficacy of intervention, height, weight, BMI, waist circumference, percent body fat, height Z-score, weight Z-score, BMI-Z score, degree of change in weight Z-score, BMI Z-score, and percent body.
Secondary outcomes (1)
Include laboratory parameters such as lipids and HbA1c.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionAug 2004
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Caroline M Apovian, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207519
- Sponsor's protocol ID
- H-24640
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.
PubMed 12365956Troiano RP, Flegal KM. Overweight children and adolescents: description, epidemiology, and demographics. Pediatrics. 1998 Mar;101(3 Pt 2):497-504.
PubMed 12224656Strauss RS, Pollack HA. Epidemic increase in childhood overweight, 1986-1998. JAMA. 2001 Dec 12;286(22):2845-8. doi: 10.1001/jama.286.22.2845.
PubMed 11735760Barlow SE, Dietz WH. Obesity evaluation and treatment: Expert Committee recommendations. The Maternal and Child Health Bureau, Health Resources and Services Administration and the Department of Health and Human Services. Pediatrics. 1998 Sep;102(3):E29. doi: 10.1542/peds.102.3.e29.
PubMed 9724677Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics. 1998 Mar;101(3 Pt 2):518-25.
PubMed 12224658Fagot-Campagna A, Pettitt DJ, Engelgau MM, Burrows NR, Geiss LS, Valdez R, Beckles GL, Saaddine J, Gregg EW, Williamson DF, Narayan KM. Type 2 diabetes among North American children and adolescents: an epidemiologic review and a public health perspective. J Pediatr. 2000 May;136(5):664-72. doi: 10.1067/mpd.2000.105141.
PubMed 10802501Ebbeling CB, Pawlak DB, Ludwig DS. Childhood obesity: public-health crisis, common sense cure. Lancet. 2002 Aug 10;360(9331):473-82. doi: 10.1016/S0140-6736(02)09678-2.
PubMed 12241736Rosenbloom AL, Joe JR, Young RS, Winter WE. Emerging epidemic of type 2 diabetes in youth. Diabetes Care. 1999 Feb;22(2):345-54. doi: 10.2337/diacare.22.2.345.
PubMed 10333956Csabi G, Torok K, Jeges S, Molnar D. Presence of metabolic cardiovascular syndrome in obese children. Eur J Pediatr. 2000 Jan-Feb;159(1-2):91-4. doi: 10.1007/pl00013812.
PubMed 10653338Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. doi: 10.1056/NEJM199709253371301.
PubMed 9302300Strauss RS, Knight J. Influence of the home environment on the development of obesity in children. Pediatrics. 1999 Jun;103(6):e85. doi: 10.1542/peds.103.6.e85.
PubMed 10353982McDuffie JR, Calis KA, Uwaifo GI, Sebring NG, Fallon EM, Hubbard VS, Yanovski JA. Three-month tolerability of orlistat in adolescents with obesity-related comorbid conditions. Obes Res. 2002 Jul;10(7):642-50. doi: 10.1038/oby.2002.87.
PubMed 12105286McDowell MA, Briefel RR, Alaimo K, Bischof AM, Caughman CR, Carroll MD, Loria CM, Johnson CL. Energy and macronutrient intakes of persons ages 2 months and over in the United States: Third National Health and Nutrition Examination Survey, Phase 1, 1988-91. Adv Data. 1994 Oct 24;(255):1-24. No abstract available.
PubMed 10141689Devaney BL, Gordon AR, Burghardt JA. Dietary intakes of students. Am J Clin Nutr. 1995 Jan;61(1 Suppl):205S-212S. doi: 10.1093/ajcn/61.1.205S.
PubMed 7832167Krebs-Smith SM, Cook A, Subar AF, Cleveland L, Friday J, Kahle LL. Fruit and vegetable intakes of children and adolescents in the United States. Arch Pediatr Adolesc Med. 1996 Jan;150(1):81-6. doi: 10.1001/archpedi.1996.02170260085014.
PubMed 8542012
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Liquid Meal Replacements in Conjunction With Lifestyle Intervention in Overweight Adolescents: A 12 Week Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT00207519
- Acronym / sponsor ID
- H-24640
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity, adolescent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 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.
In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age >85th percentile) a structured meal plan consisting of meal replacements, fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and invite at least one parent to the scheduled visits, however, no subject will be eliminated because of lack of parental involvement. In this study, we will conduct behavior modification group sessions using lessons which are structured and patterned after the suggestions documented in the LEARNÒ Program for Weight Control. Diet instruction by a registered dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan will be developed by the dietitian for subjects to follow.
Subjects will return on a weekly basis for behavioral modification groups sessions in conjunction with the liquid meal replacement diet. Blood work and physical examinations will occur pre and post intervention.
Detailed description
In this 3-month pilot study, we will introduce to 40 adolescents "at risk for overweight" (i.e., a BMI/age >85th percentile), a structured meal plan consisting of meal replacements, fruits, vegetables, whole grains, lean protein and dairy products. We will encourage and invite at least one parent to the scheduled visits, however, no subject will be eliminated because of lack of parental involvement. Parents will be encouraged to attend group sessions designed to include behavior modification, nutrition education, physical activity recommendations, and food demonstrations as a means of family support for the subject. In this study, we will conduct behavior modification group sessions using lessons which are structured and patterned after the suggestions documented in the LEARN Program for Weight Control. Diet instruction by a registered dietitian will include the appropriate use of meal replacements for a low-fat, low-calorie meal plan. Portion sizes of all foods recommended will be reviewed and a structured meal plan will be developed by the dietitian for subjects to follow. Subjects will return for 12 weekly group sessions.
For the purposes of this pilot study, mild hypertension is defined as a systolic blood pressure of >130 but <140 mm Hg and a diastolic blood pressure of >85 but <90 mm Hg. Dyslipidemia will be defined as a total cholesterol of >200 mg/dl, LDL >130 mg/dl, HDL <40 mg/dl for male subjects and <50 mg/dl for female subjects, and triacylglycerol of >150 mg/dl. Insulin resistance/diabetes shall be defined as a fasting glucose of >110 mg/dl.
Calculating Estimated Caloric Need:
Total caloric needs for subjects with a BMI >85th% for age and sex shall be calculated using the Basal Energy Expenditure multiplied by an Activity Factor (for an estimate of total energy requirements), then subtracting 250-500 calories (to achieve a 0.5 to 1 pound weight loss per week). Basal Energy Expenditure will be calculated by using the Harris-Benedict equation as follows:
Females = 655 + 4.4(wt. in lbs) + 4.3(ht. in inches) - 4.7(age in yrs) x AF Males = 66 + 6.2(wt. in lbs) +12.7(ht. in inches) - 6.8(age in yrs) x AF
Activity Factors (AF):
1.1 Restricted Activity 1.2 Sedentary (most commonly used) 1.3 Cardiovascular Activity 3x/wk
Ideal body weight is defined as:
Females = 100 lb for the first 5 ft + 5 lb for each inch over 5 ft Males = 106 lb for the first 5 ft + 6 lb for each inch over 5 ft
Subjects will be prescribed a meal plan consisting of 3 meals and 2 snacks per day. However, 2 of the 3 meals will be replaced with a liquid meal replacement which contains 220 kcal, 10 g. protein, 40 g. carbohydrate, 2.5-3 g. fat, and 5 g. dietary fiber as well as vitamin and mineral fortification. The third meal will be high in fruits, vegetables, whole grains, lean protein (30-45 g/day) and contain 600-900 kcal. Low-calorie snacks, to include additional fruit servings, will be encouraged. The meal replacements will be taken at a time the subject will be most compliant, i.e., if subject is a chronic breakfast skipper, a meal replacement will be added for the breakfast meal. All meal replacements will be provided to the subjects at no cost; subjects will complete an order form at each visit indicating flavor choices of vanilla, chocolate or strawberry for the liquid meal replacements. They will be offered the option of a meal replacement bar versus liquid meal replacement for only one of the meal replacements per day (220 kcal, 8 g. protein, 36 g. carbohydrate, 2 g. dietary fiber). These will be a choice of chocolate peanut or granola/fruit bars.
To identify and encourage dietary compliance, subjects will be provided with a food record and will be instructed to complete 3 food records per week, two week days and one weekend day, and to indicate the time of day and which type of meal replacement was consumed. This indication will be helpful in dietary instruction regarding time of day compliance is best for consuming the meal replacement. Subjects will also be instructed to return any unused meal replacements and labels from consumed meal replacements at their regularly scheduled visits as further identification of compliance to diet. A validated Youth and Adolescent Food Frequency Questionnaire or Adolescents Food Habits Checklist will be obtained at the beginning and end of the pilot study. Blood work and a physical exam will be performed pre and post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- BMI >85th% for age and sex
- Weight gain over the last 6 months of >5% than expected on the growth curve
- 12-17 years of age
Key exclusion criteria (5 listed)
- Subjects with intolerance to dairy products (e.g., lactose intolerance) will be excluded from entering into the study.
- Subjects must not have a history of clinically significant cardiac disease, congenital heart disease, any clinically significant abnormal cardiac condition, or be known to have a clinically significantly abnormal ECG. Specifically excluded conditions include coronary artery disease, clinically significant cardiac arrhythmias, and congestive heart failure.
- Subjects must not have a history of anorexia nervosa, untreated hypothyroidism (TSH greater than 4.0 mU/L for a second generation test), malignancy, pathophysiologic or genetic syndromes associated with obesity (i.e., Cushing's syndrome, Turner's syndrome, Prader Willi syndrome), major psychiatric illness such as bi-polar disorder, ADD, major depression, bulimia, schizophrenia, or psychosis.
- Subjects may not participate in any weight management program, except for that in this study, during this pilot. Subjects may not use prescription or over-the-counter (or herbal) weight control medication during the trial.
- Subjects must not have a history of alcohol or drug addiction or substance abuse within the previous 2 years.
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 |
|---|---|---|
| weekly behavioral modification group | Behavioural | – |
| liquid meal replacements | Behavioural | – |
Primary outcome
Outcome measures include for efficacy of intervention, height, weight, BMI, waist circumference, percent body fat, height Z-score, weight Z-score, BMI-Z score, degree of change in weight Z-score, BMI Z-score, and percent body.
1 secondary outcome
Include laboratory parameters such as lipids and HbA1c.
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 11 Feb 2009.
- Background: PubMed 12365956Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. doi: 10.1001/jama.288.14.1728.
- Background: PubMed 12224656Troiano RP, Flegal KM. Overweight children and adolescents: description, epidemiology, and demographics. Pediatrics. 1998 Mar;101(3 Pt 2):497-504.
- Background: PubMed 11735760Strauss RS, Pollack HA. Epidemic increase in childhood overweight, 1986-1998. JAMA. 2001 Dec 12;286(22):2845-8. doi: 10.1001/jama.286.22.2845.
- Background: PubMed 9724677Barlow SE, Dietz WH. Obesity evaluation and treatment: Expert Committee recommendations. The Maternal and Child Health Bureau, Health Resources and Services Administration and the Department of Health and Human Services. Pediatrics. 1998 Sep;102(3):E29. doi: 10.1542/peds.102.3.e29.
- Background: PubMed 12224658Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics. 1998 Mar;101(3 Pt 2):518-25.
- Background: PubMed 10802501Fagot-Campagna A, Pettitt DJ, Engelgau MM, Burrows NR, Geiss LS, Valdez R, Beckles GL, Saaddine J, Gregg EW, Williamson DF, Narayan KM. Type 2 diabetes among North American children and adolescents: an epidemiologic review and a public health perspective. J Pediatr. 2000 May;136(5):664-72. doi: 10.1067/mpd.2000.105141.
- Background: PubMed 12241736Ebbeling CB, Pawlak DB, Ludwig DS. Childhood obesity: public-health crisis, common sense cure. Lancet. 2002 Aug 10;360(9331):473-82. doi: 10.1016/S0140-6736(02)09678-2.
- Background: PubMed 10333956Rosenbloom AL, Joe JR, Young RS, Winter WE. Emerging epidemic of type 2 diabetes in youth. Diabetes Care. 1999 Feb;22(2):345-54. doi: 10.2337/diacare.22.2.345.
- Background: PubMed 10653338Csabi G, Torok K, Jeges S, Molnar D. Presence of metabolic cardiovascular syndrome in obese children. Eur J Pediatr. 2000 Jan-Feb;159(1-2):91-4. doi: 10.1007/pl00013812.
- Background: PubMed 9302300Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. doi: 10.1056/NEJM199709253371301.
- Background: PubMed 10353982Strauss RS, Knight J. Influence of the home environment on the development of obesity in children. Pediatrics. 1999 Jun;103(6):e85. doi: 10.1542/peds.103.6.e85.
- Background: PubMed 12105286McDuffie JR, Calis KA, Uwaifo GI, Sebring NG, Fallon EM, Hubbard VS, Yanovski JA. Three-month tolerability of orlistat in adolescents with obesity-related comorbid conditions. Obes Res. 2002 Jul;10(7):642-50. doi: 10.1038/oby.2002.87.
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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.
Caroline M Apovian, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing weekly behavioral modification group and liquid meal replacements in people with Overweight and Obesity, run by Boston Medical Center 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 3 inclusion and 5 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 11 Feb 2009. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Outcome measures include for efficacy of intervention, height, weight, BMI, waist circumference, percent body fat, height Z-score, weight Z-score, BMI-Z score, degree of change in weight Z-score, BMI Z-score, and percent body.. 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 NCT00207519, which also lists 27 linked publications.
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 11 Feb 2009.