Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03431831 |
| Other study ID # |
0763-16-FB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2017 |
| Est. completion date |
July 1, 2022 |
Study information
| Verified date |
July 2023 |
| Source |
University of Nebraska |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 (MI+P) for improving outcome measures within each
phenotype, and pharmacological therapy (P).
Background/significance: Obesity has long been an epidemic in the U.S. 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 methods/approach: 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
physicians/practitioners. 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 MI+P 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).
Description:
Treatment Assignment:
Both treatment groups,Those who test positive for and those who test negative for FA (food
addiction) will be assigned to one of four treatment arms, IC, MI, MI/P 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 MI+P, 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) 1:1:1:1 ratio, provided by our statistician, Dr.
Struwe. Phenotype assessment and treatment assignment will continue until the sample size
(n=10) 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, MI+P):
MI is theorized to decrease a patients ambivalence and increase his/her perceived behavioral
control (self-efficacy) for limiting HPFS and increasing 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 baseline, 1,
2,3, and 4 weeks and 2, 3, 4, 5, and 6 months to promote sustained behavioral change.50 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 his/her knowledge , limiting
HPFS/increasing CC and natural fat intake, defining FA, and explaining why it is important to
limit their HPFS/increase their CC and natural fat intake. The nurse will ask the patient to
rate the importance of limiting HPFS/increasing 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
HPFS/increasing CC and natural fat intake low, the nurse will provide information on the
benefits of limiting HPFS/increasing 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 HPFS/increase 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 them/setting 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 (90mg/8mg) initially week 1; increase by 1 tablet/day
each subsequent week until daily maintenance dose of 2 tablets twice daily (360 mg
bupropion/32 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 (90mg/8mg) initially week 1; increase by 1 tablet/day each
subsequent week until daily maintenance dose of 2 tablets twice daily (360 mg bupropion/32 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 HPFS/increase CC intake) and physical activity behaviors. IC
information sessions will occur at the same time points as the intervention sessions
(baseline, 1, 2,3, 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 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 CITI-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 2.0, 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, http://epi.grants.cancer.gov/asa24) 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 AMP.10 A strength of the ASA24-2016® is that it includes most traditional American
foods/ingredients (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 ± 3.5-5%, (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 BMI(Griffiths, 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 PCBT determinants of behavior change (the patients
perceptions toward limiting HPFS/increasing CC intake). They assess patient attitudes/beliefs
(importance score), perceived norms (perceived barriers), and perceived behavioral
control/self-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
study,(which 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 NP. 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.
