Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03431831
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2018-01-30
Brief Title:
Assessment of and Treatment Applied to Food Addiction in a Rural Healthy Behaviors Clinic
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Assessment of and Treatment Applied to Food Addiction to Encourage Self-Management of Obesity in a Rural Healthy Behaviors Clinic
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Research purpose The purpose of this pilot study is to assess obese clients for two phenotypes those testing positive and those testing negative for Food Addiction FA Yale Food Addiction Scale YFAS and determining the efficacy of four treatments usual care IC dietary and physical activity instruction individual motivational interviewing alone MI individual MI with pharmacotherapy MIP for improving outcome measures within each phenotype and pharmacological therapy P
Backgroundsignificance Obesity has long been an epidemic in the US and other countries Numerous approaches have been tried to address obesity with limited success The YFAS is a relatively new validated instrument that can help researchers and practitioners assess obese clients for food addiction Meeting the YFAS diagnosis criteria for FA suggests the need for a stronger intervention with close monitoring to assist these clients in self-management of their eating and physical activity behaviors
Proposed methodsapproach The investigators propose assessing obese clients with the YFAS as part of their intake once they are referred to the Healthy Behaviors Clinic by Regional West physicianspractitioners A nurse researcher with expertise in MI and a nurse practitioner will perform intake assessments obtain consent and randomly assign participants in each phenotype positive or negative for FA to one of three treatment groups usual care individual MI alone and individual MI with pharmacotherapy Interventions will occur over 6 months A clinical psychologist with expertise in the YFAS University of Michigan will serve as a consultant on this project and a registered dietitian University of NebraskaLincoln will serve as a co-investigator
Expected outcomes The investigators expect that MI and MIP and P will be more effective in improving outcome measures than IC We also expect that response to the treatments will differ between the two obesity phenotypes those testing positive and those testing negative for FA
Backgroundsignificance Obesity has long been an epidemic in the US and other countries Numerous approaches have been tried to address obesity with limited success The YFAS is a relatively new validated instrument that can help researchers and practitioners assess obese clients for food addiction Meeting the YFAS diagnosis criteria for FA suggests the need for a stronger intervention with close monitoring to assist these clients in self-management of their eating and physical activity behaviors
Proposed methodsapproach The investigators propose assessing obese clients with the YFAS as part of their intake once they are referred to the Healthy Behaviors Clinic by Regional West physicianspractitioners A nurse researcher with expertise in MI and a nurse practitioner will perform intake assessments obtain consent and randomly assign participants in each phenotype positive or negative for FA to one of three treatment groups usual care individual MI alone and individual MI with pharmacotherapy Interventions will occur over 6 months A clinical psychologist with expertise in the YFAS University of Michigan will serve as a consultant on this project and a registered dietitian University of NebraskaLincoln will serve as a co-investigator
Expected outcomes The investigators expect that MI and MIP and P will be more effective in improving outcome measures than IC We also expect that response to the treatments will differ between the two obesity phenotypes those testing positive and those testing negative for FA
Detailed Description:
Treatment Assignment
Both treatment groupsThose who test positive for and those who test negative for FA food addiction will be assigned to one of four treatment arms IC MI MIP and P All will receive dietary and exercise information
After consenting each participant be administered the YFAS to determine their obesity phenotype positive or negative for FA Participants within each phenotype will be randomly assigned to one of the intervention MI or MIP or P or the IC information control diet and physical activity instruction which will be no less than current standard of care treatment groups using a randomization schedule assignments in numbered sealed opaque envelopes one set for each phenotype 1111 ratio provided by our statistician Dr Struwe Phenotype assessment and treatment assignment will continue until the sample size n10 is met for each phenotype-treatment group category Those participants in the control group will be seen at the same time periods as each treatment group to maintain their interaction time with the clinic Participants will receive diet and exercise instruction at each time point
Intervention Conditions MI MIP
MI is theorized to decrease a patients ambivalence and increase hisher perceived behavioral control self-efficacy for limiting highly processed and high in fat and sugar foods HPFS and increasing complex carbohydrates CC intake by emphasizing personal choice and control in decision-making and by affirming the patients self-management ability Interventionist nurses will deliver MI sessions following data collection at baseline1 23 and 4 weeks and 2 3 4 5 and 6 months to promote sustained behavioral change50 A written MI algorithm will be used to ensure uniform implementation of the intervention
MI will be operationalized by the nurse asking the patient about hisher knowledge limiting HPFSincreasing CC and natural fat intake defining FA and explaining why it is important to limit their HPFSincrease their CC and natural fat intake The nurse will ask the patient to rate the importance of limiting HPFSincreasing CC and natural fat intake scale of 1-10 and their confidence in their ability to do so scale of 1-10 The nurse will focus on the lower score and ask the patient why they chose that score and what they thought it would take to increase the number If the patient rates the importance of understanding of limiting HPFSincreasing CC and natural fat intake low the nurse will provide information on the benefits of limiting HPFSincreasing CC and natural fat intake to reduce the their risk of obesity diabetes heart disease and numerous other co-morbidities associated with overweight If the patient rates their confidence in their ability to limit HPFSincrease CC and natural fat intake as low the nurse will provide the patient with strategies to decrease barriers and increase confidence such as a list of healthy snack food choices stepped changes 3 sodas per day to 2 sodas and 1 water per day etc and having the patient choose healthy foods at the store The same questions will be asked at each time point Nurse responses will be tailored to the specific motivational issues of each individual patient at each time point During each session the nurse will document the patients responses to the MI algorithm levels of confidence importance and readiness to change their perceived barriers and concerns and suggestions to address themsetting achievable goals The MI documentation form will ensure that all nurses collect the same data and provides a record that the nurses can reference during their sessions to help them adjust each MI session to the patients individual needs If a participant reveals a new barrier that is not included in the training materials the nurses will meet with team members to discuss the new barrier and strategies to address it will be shared with all interventionists
In the group with pharmacotherapy added to the MI the naltrexone-buproprion Contrave protocol will be added to the patients intervention Dosing protocols will be followed for treatment of obesity Orally 1 tablet 90mg8mg initially week 1 increase by 1 tabletday each subsequent week until daily maintenance dose of 2 tablets twice daily 360 mg bupropion32 mg naltrexone is achieved at the start of week 4 Use will be discontinued at month 4 if no clinical response is observed This drug Contrave is to be taken with a high fat meal
In the pharmacotherapy group alone Dosing protocols will be followed for treatment of obesity Orally 1 tablet 90mg8mg initially week 1 increase by 1 tabletday each subsequent week until daily maintenance dose of 2 tablets twice daily 360 mg bupropion32 mg naltrexone is achieved at the start of week 4 Use will be discontinued at month 4 if no clinical response is observed This drug Contrave is to be taken with a high fat meal
IC Information Control Condition
The IC control group will receive diet and physical activity information to encourage them to adopt healthier eating limit HPFSincrease CC intake and physical activity behaviors IC information sessions will occur at the same time points as the intervention sessions baseline 1 23 and 4 weeks and 2 3 4 5 and 6 months and will be similar in length The PI and co-PIs will develop information packets for each session self-management avoiding highly processed low-nutrient simple carbohydrates LNSC foods low intensity physical activity avoiding highly processed fatty foods medium intensity physical activity avoiding LNSC beverages importance of water as a beverage to hydrate and reduce cravings avoiding high fat beverages high intensity physical activity importance of CC intake
Data Collection
All research personnel will be Collaborative Institutional Training Initiative CITI Program-trained A nursing student will assist the nurse researchers with data collection Each data collector will undergo fidelity checks performed by the PI for each measurement procedure before they will be allowed to collect data They will also be trained in using the ASA24-2016 dietary recall so they can assist the patients as needed
Outcome Measures
YFAS Gearhardt et al 2009 2013 The current version of the YFAS the YFAS 20 will be used to assess participants obesity phenotype positive or negative for FA This measures adapts the eleven DSM-5 diagnostic criteria for substance-related and addictive disorders when the substance is HPFS foods In order to meet the diagnostic threshold on the YFAS individuals must report at least two of the eleven diagnostic indicators of FA plus clinically significant impairment or distress
Automated Self-Administered 24-hour Recall version ASA24-2016
The Automated Self-Administered 24-hour Recall version ASA24-2016 National Cancer Institute httpepigrantscancergovasa24 will be completed at each time point to assess changes in patients dietary intake This web-based 24 hour dietary recall instrument has been used effectively by hundreds of researchers and has face validity and similar intake results to the AMP10 A strength of the ASA24-2016 is that it includes most traditional American foodsingredients Thompson 2015
Height The participants height will be used in determining BMI and BIA measures We will use the average of 2 heights cm measured with the Seca EC0123 stadiometer During measurement patients will be in socked feet with heels placed against the back of the platform and facing straight forward
Body Composition Bioelectrical impedance analysis BIA will be used to determine body composition Estimated standard error for BIA is 35-5 American College of Sports Medicine 2009 The investigators will use a Tanita SC-250 body composition analyzer and follow a standardized protocol to measure percent body fat body fat mass fat free mass percent body water muscle mass bone mass BMI and visceral fat The software also classifies patients as underfat healthy overfat or obese based on percent body fat age and gender
Waist circumference The investigators will use the average of 2 measurements cm performed with the patient standing erect with their arms at their sides Waist circumference will be measured at the uppermost lateral border of the right ilium at the end of normal expiration using an inelastic tape measure positioned around the trunk parallel to the floor This measure is included because it is a better indicator of body fat and therefore health risk than BMIGriffiths 2012 In addition results of a recent study in this population demonstrated that waist circumference has potential as a means of identifying patients with or at risk for obesity and hypertension Aguirre 2015
Blood Pressure The investigators will use the average of 2 blood pressure measurements performed using an Omron HEM- 907 automatic blood pressure monitor The measurements will be performed while the patient is quiet and still using the appropriate sized cuff placed snugly around the upper arm approximately 2 to 3 cm above the antecubital fossa with the mark on the cuff aligned with the artery
Determinants of Change Measures
MI Algorithm Questions These reflect the Predicting and Changing Behavior Theory PCBT determinants of behavior change the patients perceptions toward limiting HPFSincreasing CC intake They assess patient attitudesbeliefs importance score perceived norms perceived barriers and perceived behavioral controlself-efficacy confidence score These measures will be recorded by the interventionist nurses during each MI session for their assigned patients
If a subject experiences success in managing their weight while participating in the studywhich will be determined by a 5 decrease in BMI or body fat or total body mass over 4 months the subject may continue with the weight management plan after completing all study related visits
All participants may continue with clinic visits following the study and may have available to them usual care MI Contrave unless they have taken it in the study and it was not effective and bariatric surgery options
All subjects taking Contrave will be screened at each visit for suicidal ideation In addition they will be asked to call Dr Bowman immediately if they have any such feelings or symptoms of suicidal ideation If they present with suicidal ideation Dr Bowman will interview them using the Suicide Screening Algorithm see documents to determine the severity of the symptoms and make additional medical referrals as necessary If the case is emergent they will be immediately escorted to the ER or asked to come into the ER if it is a phone visit If the case is urgent they will be referred to psychiatric personnel in the office where Dr Bowman practices as a Psychiatric Nurse Practioner They will be withdrawn from the study at this time and Dr Aguirre will be notified Dr Bowman will follow up with these patients
At the six month visit a PHQ-9 and the YFAS from the WALI will be readministered An appt for a 12 month sustainability measure will be set up
Both treatment groupsThose who test positive for and those who test negative for FA food addiction will be assigned to one of four treatment arms IC MI MIP and P All will receive dietary and exercise information
After consenting each participant be administered the YFAS to determine their obesity phenotype positive or negative for FA Participants within each phenotype will be randomly assigned to one of the intervention MI or MIP or P or the IC information control diet and physical activity instruction which will be no less than current standard of care treatment groups using a randomization schedule assignments in numbered sealed opaque envelopes one set for each phenotype 1111 ratio provided by our statistician Dr Struwe Phenotype assessment and treatment assignment will continue until the sample size n10 is met for each phenotype-treatment group category Those participants in the control group will be seen at the same time periods as each treatment group to maintain their interaction time with the clinic Participants will receive diet and exercise instruction at each time point
Intervention Conditions MI MIP
MI is theorized to decrease a patients ambivalence and increase hisher perceived behavioral control self-efficacy for limiting highly processed and high in fat and sugar foods HPFS and increasing complex carbohydrates CC intake by emphasizing personal choice and control in decision-making and by affirming the patients self-management ability Interventionist nurses will deliver MI sessions following data collection at baseline1 23 and 4 weeks and 2 3 4 5 and 6 months to promote sustained behavioral change50 A written MI algorithm will be used to ensure uniform implementation of the intervention
MI will be operationalized by the nurse asking the patient about hisher knowledge limiting HPFSincreasing CC and natural fat intake defining FA and explaining why it is important to limit their HPFSincrease their CC and natural fat intake The nurse will ask the patient to rate the importance of limiting HPFSincreasing CC and natural fat intake scale of 1-10 and their confidence in their ability to do so scale of 1-10 The nurse will focus on the lower score and ask the patient why they chose that score and what they thought it would take to increase the number If the patient rates the importance of understanding of limiting HPFSincreasing CC and natural fat intake low the nurse will provide information on the benefits of limiting HPFSincreasing CC and natural fat intake to reduce the their risk of obesity diabetes heart disease and numerous other co-morbidities associated with overweight If the patient rates their confidence in their ability to limit HPFSincrease CC and natural fat intake as low the nurse will provide the patient with strategies to decrease barriers and increase confidence such as a list of healthy snack food choices stepped changes 3 sodas per day to 2 sodas and 1 water per day etc and having the patient choose healthy foods at the store The same questions will be asked at each time point Nurse responses will be tailored to the specific motivational issues of each individual patient at each time point During each session the nurse will document the patients responses to the MI algorithm levels of confidence importance and readiness to change their perceived barriers and concerns and suggestions to address themsetting achievable goals The MI documentation form will ensure that all nurses collect the same data and provides a record that the nurses can reference during their sessions to help them adjust each MI session to the patients individual needs If a participant reveals a new barrier that is not included in the training materials the nurses will meet with team members to discuss the new barrier and strategies to address it will be shared with all interventionists
In the group with pharmacotherapy added to the MI the naltrexone-buproprion Contrave protocol will be added to the patients intervention Dosing protocols will be followed for treatment of obesity Orally 1 tablet 90mg8mg initially week 1 increase by 1 tabletday each subsequent week until daily maintenance dose of 2 tablets twice daily 360 mg bupropion32 mg naltrexone is achieved at the start of week 4 Use will be discontinued at month 4 if no clinical response is observed This drug Contrave is to be taken with a high fat meal
In the pharmacotherapy group alone Dosing protocols will be followed for treatment of obesity Orally 1 tablet 90mg8mg initially week 1 increase by 1 tabletday each subsequent week until daily maintenance dose of 2 tablets twice daily 360 mg bupropion32 mg naltrexone is achieved at the start of week 4 Use will be discontinued at month 4 if no clinical response is observed This drug Contrave is to be taken with a high fat meal
IC Information Control Condition
The IC control group will receive diet and physical activity information to encourage them to adopt healthier eating limit HPFSincrease CC intake and physical activity behaviors IC information sessions will occur at the same time points as the intervention sessions baseline 1 23 and 4 weeks and 2 3 4 5 and 6 months and will be similar in length The PI and co-PIs will develop information packets for each session self-management avoiding highly processed low-nutrient simple carbohydrates LNSC foods low intensity physical activity avoiding highly processed fatty foods medium intensity physical activity avoiding LNSC beverages importance of water as a beverage to hydrate and reduce cravings avoiding high fat beverages high intensity physical activity importance of CC intake
Data Collection
All research personnel will be Collaborative Institutional Training Initiative CITI Program-trained A nursing student will assist the nurse researchers with data collection Each data collector will undergo fidelity checks performed by the PI for each measurement procedure before they will be allowed to collect data They will also be trained in using the ASA24-2016 dietary recall so they can assist the patients as needed
Outcome Measures
YFAS Gearhardt et al 2009 2013 The current version of the YFAS the YFAS 20 will be used to assess participants obesity phenotype positive or negative for FA This measures adapts the eleven DSM-5 diagnostic criteria for substance-related and addictive disorders when the substance is HPFS foods In order to meet the diagnostic threshold on the YFAS individuals must report at least two of the eleven diagnostic indicators of FA plus clinically significant impairment or distress
Automated Self-Administered 24-hour Recall version ASA24-2016
The Automated Self-Administered 24-hour Recall version ASA24-2016 National Cancer Institute httpepigrantscancergovasa24 will be completed at each time point to assess changes in patients dietary intake This web-based 24 hour dietary recall instrument has been used effectively by hundreds of researchers and has face validity and similar intake results to the AMP10 A strength of the ASA24-2016 is that it includes most traditional American foodsingredients Thompson 2015
Height The participants height will be used in determining BMI and BIA measures We will use the average of 2 heights cm measured with the Seca EC0123 stadiometer During measurement patients will be in socked feet with heels placed against the back of the platform and facing straight forward
Body Composition Bioelectrical impedance analysis BIA will be used to determine body composition Estimated standard error for BIA is 35-5 American College of Sports Medicine 2009 The investigators will use a Tanita SC-250 body composition analyzer and follow a standardized protocol to measure percent body fat body fat mass fat free mass percent body water muscle mass bone mass BMI and visceral fat The software also classifies patients as underfat healthy overfat or obese based on percent body fat age and gender
Waist circumference The investigators will use the average of 2 measurements cm performed with the patient standing erect with their arms at their sides Waist circumference will be measured at the uppermost lateral border of the right ilium at the end of normal expiration using an inelastic tape measure positioned around the trunk parallel to the floor This measure is included because it is a better indicator of body fat and therefore health risk than BMIGriffiths 2012 In addition results of a recent study in this population demonstrated that waist circumference has potential as a means of identifying patients with or at risk for obesity and hypertension Aguirre 2015
Blood Pressure The investigators will use the average of 2 blood pressure measurements performed using an Omron HEM- 907 automatic blood pressure monitor The measurements will be performed while the patient is quiet and still using the appropriate sized cuff placed snugly around the upper arm approximately 2 to 3 cm above the antecubital fossa with the mark on the cuff aligned with the artery
Determinants of Change Measures
MI Algorithm Questions These reflect the Predicting and Changing Behavior Theory PCBT determinants of behavior change the patients perceptions toward limiting HPFSincreasing CC intake They assess patient attitudesbeliefs importance score perceived norms perceived barriers and perceived behavioral controlself-efficacy confidence score These measures will be recorded by the interventionist nurses during each MI session for their assigned patients
If a subject experiences success in managing their weight while participating in the studywhich will be determined by a 5 decrease in BMI or body fat or total body mass over 4 months the subject may continue with the weight management plan after completing all study related visits
All participants may continue with clinic visits following the study and may have available to them usual care MI Contrave unless they have taken it in the study and it was not effective and bariatric surgery options
All subjects taking Contrave will be screened at each visit for suicidal ideation In addition they will be asked to call Dr Bowman immediately if they have any such feelings or symptoms of suicidal ideation If they present with suicidal ideation Dr Bowman will interview them using the Suicide Screening Algorithm see documents to determine the severity of the symptoms and make additional medical referrals as necessary If the case is emergent they will be immediately escorted to the ER or asked to come into the ER if it is a phone visit If the case is urgent they will be referred to psychiatric personnel in the office where Dr Bowman practices as a Psychiatric Nurse Practioner They will be withdrawn from the study at this time and Dr Aguirre will be notified Dr Bowman will follow up with these patients
At the six month visit a PHQ-9 and the YFAS from the WALI will be readministered An appt for a 12 month sustainability measure will be set up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None