Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194194
Status:
COMPLETED
Last Update Posted:
2009-03-17
First Post:
2005-09-12
Brief Title:
Healthetech Inc SMART Study
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
The Effect of Measuring Resting Metabolic Rate RMR in the Context of Moderate or Intensive Behavior Modification Treatment on Weight Loss
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to gain experience with the HealtheTech measurement system BalanceLog in the context of a clinical trial and to develop the related treatment protocols In this study the aim is to evaluate two interventions one moderate and the other intensive behavioral management The development and evaluation of a HealtheTech protocol across these two treatment settings will provide useful data about implementation eg technical issues clinical issues participant satisfaction and outcomes weight loss retention These data can provide empirical and clinical support for practice guidelines
Detailed Description:
Study Duration The duration of the study is approximately one year 51 weeks divided into four phases 1 Pre-study 2 Baseline 3 Intervention and 4 Maintenance Participants will be oriented to the procedures and equipment during the pre-study phase first 3 weeks During the baseline and intervention phases 24 weeks participants will be undergoing weight loss treatment Participants will maintain their weight loss during the maintenance phase 24 weeks
Subject Recruitment and Selection Participants will be 80 participants BMI of 25 to 43 kgm2 age 21 years who have access to a personal computer PC The anticipated gender balance in the study group will be 80 females and 20 males Forty participants will be recruited at the University of Pennsylvania and 40 at St Lukes Hospital in New York City Participants will be randomly assigned to a moderate or intensive intervention described below
Research Design This study is divided into four phases
Phase 1 Pre-study Screening medical and nutritional evaluation RMR measurement Balance Log orientation There will be 3 weeks in which participants learn how to use the BalanceLog Pro technology including transferring information to the clinic ie at week -3 become familiar with logging and establish a Balance Log Pro account log meals and activity and upload data to the Balance Log Pro at week -2 learn how to use special Balance Log functions such as adding foods and receive feedback via email concerning Balance Log Pro upload at week -1 In order to be randomized participants will need to be proficient in the use of technology so that that treatment can focus on inducing weight loss rather than learning the software
Phase 2 Baseline All participants will participate in weekly individual meetings with the dietitian RD for 6 weeks This is designed to establish a solid base for the study and provide a good start on weight loss
Phase 3 Intervention Individuals will be randomized to either a moderate or intensive intervention Paricipants in the moderate intervention will meet individually with the RD once per month Individuals in the intensive intervention will meet with the RD twice per month This Phase continues for 18 weeks - this makes the weight loss phase of the study 6 months in length A second DEXA scan will be completed at the end of this study phase
Phase 4 Maintenance From 6 to 12 months all participants will shift to a maintenance phase and be contacted and measured at 9 and 12 months At these timepoints participants will meet individually with the RD All individuals use the same HETC tools MedGem BalanceLog and BalanceLog Pro
Behavioral treatment will be based on the LEARN Program for Weight Control Manual Participants will be encouraged to consume a low-calorie low-fat diet ie 30 of calories from fat 15 of calories from protein and 55 of calories from carbohydrate The Balance Log a software tool will be used to establish a calorie prescription based on a variety of individual factors like RMR lifestyle activity and physical activity level as described in the Balance Log software
1 Moderate Frequency Participants in this condition will be provided information about the treatment program LEARN Manual schedule and how to use Balance Log version 211 and professional web-based program to log food intake and activity Participants in this group will meet with a dietitian individually on a weekly basis for the first 6 weeks then once a month for the remaining 18 weeks of the weight loss phase During the last 6 months of the study ie weight maintenance phase participants will meet with a dietitian for quarterly follow-up
2 Intensive Frequency Participants in this condition will be provided information about the treatment program LEARN Manual schedule and how to use Balance Log version 211 and professional web-based program to log food intake and activity Participants in this group will meet with a dietitian individually on a weekly basis for the first 6 weeks then biweekly for the remaining 18 weeks of the weight loss phase During the last 6 months of the study ie weight maintenance phase participants will meet with a dietitian for quarterly follow-up
Program materials The materials will be based on the current weight management program at the University of Pennsylvania Additional materials will be developed or altered to reflect HealtheTech messaging RMR energy balance self-monitoring etc HealtheTech will provide some support for content and layout graphics and professional reproduction
A complete set of Program Guideline materials will be developed as a result of the study The principal investigators will develop materials such as
Topical outline of the 20 sessions for clinicians Talking point summaries for each session What to do summaries for the participants Skill builders to be used in each session Key messages sequenced throughout the program
Assessments The following assessments will be performed
Blood tests Routine blood work including a comprehensive metabolic panel complete blood count and lipid panel will be performed during baseline and week 24 Blood samples will be discarded following analysis
Waist circumference Waist circumference will be measured at baseline and on weeks 2 4 8 12 16 20 24 38 and 52 Waist circumference will be measured at the mid-point between the right iliac crest and the bottom of the right rib cage using a Gulick measuring tape
Body composition Body composition will be measured by dual x-ray absorptiometry DEXA at baseline and week 24 DEXA will provide estimates of total body fat and fat free mass and bone mineral density hip spine and total body The body composition unit will be performed at the Childrens Hospital of Philadelphia CHOP body composition laboratory which is located on 3550 Market 4th floor A urine pregnancy test will be given to all women prior to each DEXA scan
Weight Weight will be measured at screening baseline and at each treatment visit using a digital scale with subjects dressed in light clothing and without shoes Height will be measured using a stadiometer at screening and at weeks 52 and 104
Blood Pressure Blood pressure will be measured at screening baseline and weeks 2 4 8 12 16 20 24 38 and 52 On each occasion two readings will be taken 1 minute apart after you have been seated for 5 minutes All measurements will be performed at the WEDP
Resting Metabolic Rate The MedGem will be used for all RMR measurements RMR measurements will be conducted at baseline and weeks 2 4 8 12 16 20 24 38 and 52 All participants will have their RMR measured once during the pre-study phase to develop familiarization with the test RMR measurements will be repeated when the opinion of the clinician is there has been a problem or the result is outside of reasonable Harris-Benedict the traditional RMR prediction formula 15 range The MINIMUM rate of weight loss will be calculated based on 10 weight loss divided over 24 weeks Examples 240 lb participant 24 lb weight loss over 24 weeks 1 lbweek 500 kcal deficit per day whereas a 180 lbs participant would have a target of 18 lbs over the 24 weeks or 067 lbsweek or a daily caloric deficit of 367 kcalday
Caloric Budget Adjustments Based on RMR Adjustments to calorie budgets will be done monthly when appropriate Although we are measuring RMR at week 2 calorie budgets will not be adjusted at this time The investigators will provide a recommendation for the number of kcalday that a RMR must change before the Individualized Energy Balance Prescription IEBP is recalculated For example if there is a 50 kcalday difference then it may not be meaningful to change the IEBP that only represents a change of about 3 whereas if the change is 150 or more kcalday it is reasonable to change the recommended intake
Resting metabolic rate will be measured under strict resting conditions
12 hour fast including caffeine 12 hours post-exercise 30 minute rest prior to the measurement A 2 to 3 minute familiarization will be done with the device during the resting period
Dietary Intake and Activity Individuals will be required to log their food and exercise daily for 6 months They will log using BalanceLog on their PC One of the inclusion criterions will be daily access to a PC The BalanceLog will be used to establish an Energy Balance Prescription for all participants Macronutrient composition will be chosen by the participant however the recommendation will be to use a relatively standard low 30 fat diet with a minimum of 40 carbohydrate BalanceLog Pro is a web-based program allowing professionals to review individuals BalanceLog records and reports remotely
Questionnaires A qualitative assessment of logging will be conducted at two time points 3 months and 6 months Process measures including ease and frequency of use participant satisfaction ratings of professional staff
Potential Risks The program of weight loss treatment presents few risks to participants Psychological risks include subjective distress in participants who regain their weight We will acknowledge participants disappointment and discuss their experiences from the perspectives of others who have regained weight
The potential risks of the study are primarily associated with the assessment measures specifically the DEXA and blood testing The blood tests present a minor risk of bruising Every effort will be made to minimize these risks including a review of participants health before the testing
Informed Consent Participants will be recruited from public service announcements notices in local newspapers and referrals from physicians offices at the three sites Applicants will be screened by phone to determine that they meet the recruitment criteria have no obvious contraindications to treatment and remain interested in the study after it has been described Screenings will be conducted by research coordinators following a written protocol Persons who appear appropriate to participate will be scheduled for an initial interview In the face-to-face interview applicants will be informed of the nature and requirements of the study including randomization to treatment conditions They will be provided a written description of all study details and asked to give their informed consent to participate in further assessment and treatment Candidates not wishing to participate or who do not meet criteria will be offered a referral to an appropriate program
Protection of Participants Risks of complications will be reduced by carefully selecting participants for treatment We have clearly defined the contraindications and will inform the participants primary care physicians of these contraindications Participants will receive blood tests at frequent intervals and results of these tests will be monitored by a physician to ensure participant safety during weight loss Both participants and their primary care physicians will be made aware of any abnormal findings
Data will be kept in a locked file cabinet to ensure confidentiality In addition guidelines concerning the confidentiality of group treatment sessions will be reviewed with participants at the initial interview and at the first treatment session Code numbers will be assigned to each participant to maximize anonymity while entering data
Subject Recruitment and Selection Participants will be 80 participants BMI of 25 to 43 kgm2 age 21 years who have access to a personal computer PC The anticipated gender balance in the study group will be 80 females and 20 males Forty participants will be recruited at the University of Pennsylvania and 40 at St Lukes Hospital in New York City Participants will be randomly assigned to a moderate or intensive intervention described below
Research Design This study is divided into four phases
Phase 1 Pre-study Screening medical and nutritional evaluation RMR measurement Balance Log orientation There will be 3 weeks in which participants learn how to use the BalanceLog Pro technology including transferring information to the clinic ie at week -3 become familiar with logging and establish a Balance Log Pro account log meals and activity and upload data to the Balance Log Pro at week -2 learn how to use special Balance Log functions such as adding foods and receive feedback via email concerning Balance Log Pro upload at week -1 In order to be randomized participants will need to be proficient in the use of technology so that that treatment can focus on inducing weight loss rather than learning the software
Phase 2 Baseline All participants will participate in weekly individual meetings with the dietitian RD for 6 weeks This is designed to establish a solid base for the study and provide a good start on weight loss
Phase 3 Intervention Individuals will be randomized to either a moderate or intensive intervention Paricipants in the moderate intervention will meet individually with the RD once per month Individuals in the intensive intervention will meet with the RD twice per month This Phase continues for 18 weeks - this makes the weight loss phase of the study 6 months in length A second DEXA scan will be completed at the end of this study phase
Phase 4 Maintenance From 6 to 12 months all participants will shift to a maintenance phase and be contacted and measured at 9 and 12 months At these timepoints participants will meet individually with the RD All individuals use the same HETC tools MedGem BalanceLog and BalanceLog Pro
Behavioral treatment will be based on the LEARN Program for Weight Control Manual Participants will be encouraged to consume a low-calorie low-fat diet ie 30 of calories from fat 15 of calories from protein and 55 of calories from carbohydrate The Balance Log a software tool will be used to establish a calorie prescription based on a variety of individual factors like RMR lifestyle activity and physical activity level as described in the Balance Log software
1 Moderate Frequency Participants in this condition will be provided information about the treatment program LEARN Manual schedule and how to use Balance Log version 211 and professional web-based program to log food intake and activity Participants in this group will meet with a dietitian individually on a weekly basis for the first 6 weeks then once a month for the remaining 18 weeks of the weight loss phase During the last 6 months of the study ie weight maintenance phase participants will meet with a dietitian for quarterly follow-up
2 Intensive Frequency Participants in this condition will be provided information about the treatment program LEARN Manual schedule and how to use Balance Log version 211 and professional web-based program to log food intake and activity Participants in this group will meet with a dietitian individually on a weekly basis for the first 6 weeks then biweekly for the remaining 18 weeks of the weight loss phase During the last 6 months of the study ie weight maintenance phase participants will meet with a dietitian for quarterly follow-up
Program materials The materials will be based on the current weight management program at the University of Pennsylvania Additional materials will be developed or altered to reflect HealtheTech messaging RMR energy balance self-monitoring etc HealtheTech will provide some support for content and layout graphics and professional reproduction
A complete set of Program Guideline materials will be developed as a result of the study The principal investigators will develop materials such as
Topical outline of the 20 sessions for clinicians Talking point summaries for each session What to do summaries for the participants Skill builders to be used in each session Key messages sequenced throughout the program
Assessments The following assessments will be performed
Blood tests Routine blood work including a comprehensive metabolic panel complete blood count and lipid panel will be performed during baseline and week 24 Blood samples will be discarded following analysis
Waist circumference Waist circumference will be measured at baseline and on weeks 2 4 8 12 16 20 24 38 and 52 Waist circumference will be measured at the mid-point between the right iliac crest and the bottom of the right rib cage using a Gulick measuring tape
Body composition Body composition will be measured by dual x-ray absorptiometry DEXA at baseline and week 24 DEXA will provide estimates of total body fat and fat free mass and bone mineral density hip spine and total body The body composition unit will be performed at the Childrens Hospital of Philadelphia CHOP body composition laboratory which is located on 3550 Market 4th floor A urine pregnancy test will be given to all women prior to each DEXA scan
Weight Weight will be measured at screening baseline and at each treatment visit using a digital scale with subjects dressed in light clothing and without shoes Height will be measured using a stadiometer at screening and at weeks 52 and 104
Blood Pressure Blood pressure will be measured at screening baseline and weeks 2 4 8 12 16 20 24 38 and 52 On each occasion two readings will be taken 1 minute apart after you have been seated for 5 minutes All measurements will be performed at the WEDP
Resting Metabolic Rate The MedGem will be used for all RMR measurements RMR measurements will be conducted at baseline and weeks 2 4 8 12 16 20 24 38 and 52 All participants will have their RMR measured once during the pre-study phase to develop familiarization with the test RMR measurements will be repeated when the opinion of the clinician is there has been a problem or the result is outside of reasonable Harris-Benedict the traditional RMR prediction formula 15 range The MINIMUM rate of weight loss will be calculated based on 10 weight loss divided over 24 weeks Examples 240 lb participant 24 lb weight loss over 24 weeks 1 lbweek 500 kcal deficit per day whereas a 180 lbs participant would have a target of 18 lbs over the 24 weeks or 067 lbsweek or a daily caloric deficit of 367 kcalday
Caloric Budget Adjustments Based on RMR Adjustments to calorie budgets will be done monthly when appropriate Although we are measuring RMR at week 2 calorie budgets will not be adjusted at this time The investigators will provide a recommendation for the number of kcalday that a RMR must change before the Individualized Energy Balance Prescription IEBP is recalculated For example if there is a 50 kcalday difference then it may not be meaningful to change the IEBP that only represents a change of about 3 whereas if the change is 150 or more kcalday it is reasonable to change the recommended intake
Resting metabolic rate will be measured under strict resting conditions
12 hour fast including caffeine 12 hours post-exercise 30 minute rest prior to the measurement A 2 to 3 minute familiarization will be done with the device during the resting period
Dietary Intake and Activity Individuals will be required to log their food and exercise daily for 6 months They will log using BalanceLog on their PC One of the inclusion criterions will be daily access to a PC The BalanceLog will be used to establish an Energy Balance Prescription for all participants Macronutrient composition will be chosen by the participant however the recommendation will be to use a relatively standard low 30 fat diet with a minimum of 40 carbohydrate BalanceLog Pro is a web-based program allowing professionals to review individuals BalanceLog records and reports remotely
Questionnaires A qualitative assessment of logging will be conducted at two time points 3 months and 6 months Process measures including ease and frequency of use participant satisfaction ratings of professional staff
Potential Risks The program of weight loss treatment presents few risks to participants Psychological risks include subjective distress in participants who regain their weight We will acknowledge participants disappointment and discuss their experiences from the perspectives of others who have regained weight
The potential risks of the study are primarily associated with the assessment measures specifically the DEXA and blood testing The blood tests present a minor risk of bruising Every effort will be made to minimize these risks including a review of participants health before the testing
Informed Consent Participants will be recruited from public service announcements notices in local newspapers and referrals from physicians offices at the three sites Applicants will be screened by phone to determine that they meet the recruitment criteria have no obvious contraindications to treatment and remain interested in the study after it has been described Screenings will be conducted by research coordinators following a written protocol Persons who appear appropriate to participate will be scheduled for an initial interview In the face-to-face interview applicants will be informed of the nature and requirements of the study including randomization to treatment conditions They will be provided a written description of all study details and asked to give their informed consent to participate in further assessment and treatment Candidates not wishing to participate or who do not meet criteria will be offered a referral to an appropriate program
Protection of Participants Risks of complications will be reduced by carefully selecting participants for treatment We have clearly defined the contraindications and will inform the participants primary care physicians of these contraindications Participants will receive blood tests at frequent intervals and results of these tests will be monitored by a physician to ensure participant safety during weight loss Both participants and their primary care physicians will be made aware of any abnormal findings
Data will be kept in a locked file cabinet to ensure confidentiality In addition guidelines concerning the confidentiality of group treatment sessions will be reviewed with participants at the initial interview and at the first treatment session Code numbers will be assigned to each participant to maximize anonymity while entering data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None