Trial Outcomes & Findings for Assessment of and Treatment Applied to Food Addiction in a Rural Healthy Behaviors Clinic (NCT NCT03431831)

NCT ID: NCT03431831

Last Updated: 2024-08-29

Results Overview

Weight in lbs

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

86 participants

Primary outcome timeframe

difference between baseline and 6 months

Results posted on

2024-08-29

Participant Flow

Additional persons enrolled to replace withdrawals.

Participant milestones

Participant milestones
Measure	FA+ Intervention Control All participants will receive diet/physical intervention. One arm will receive diet/physical activity intervention alone as a Intervention/usual care condition. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages.	FA+ Counselling These participants will receive usual care and counseling in the form of motivational interviewing weekly with goal setting for the first 5 weeks and monthly intervention for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating.	FA+ Contrave These participants will receive usual care and prescription of Contrave for weight loss. They will be seen weekly for the first 5 weeks and monthly for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly.	FA+ Contrave and Counseling These participants will receive usual care of diet and physical activity recommendations and Contrave prescription and counseling (motivational interviewing interventions weekly for the first 5 weeks and then monthly for 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly. Contrave and Counseling: This group of participants will receive a combination of all the above interventions including diet/physical activity prescription, motivational interviewing and Contrave.	FA- Intervention Control All participants will receive diet/physical intervention. One arm will receive diet/physical activity intervention alone as a Intervention/usual care condition. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages.	FA- Counseling These participants will receive usual care and counseling in the form of motivational interviewing weekly with goal setting for the first 5 weeks and monthly intervention for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating.	FA-Contrave These participants will receive usual care and prescription of Contrave for weight loss. They will be seen weekly for the first 5 weeks and monthly for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly.	FA- Contrave and Counseling These participants will receive usual care of diet and physical activity recommendations and Contrave prescription and counseling (motivational interviewing interventions weekly for the first 5 weeks and then monthly for 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly. Contrave and Counseling: This group of participants will receive a combination of all the above interventions including diet/physical activity prescription, motivational interviewing and Contrave.
Overall Study STARTED	8	10	10	10	13	14	11	10
Overall Study COMPLETED	6	8	8	9	9	10	10	9
Overall Study NOT COMPLETED	2	2	2	1	4	4	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of and Treatment Applied to Food Addiction in a Rural Healthy Behaviors Clinic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FA+ Intervention Control n=8 Participants All participants will receive diet/physical intervention. One arm will receive diet/physical activity intervention alone as a Intervention/usual care condition. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages.	FA+ Counselling n=10 Participants These participants will receive usual care and counseling in the form of motivational interviewing weekly with goal setting for the first 5 weeks and monthly intervention for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating.	FA+ Contrave n=10 Participants These participants will receive usual care and prescription of Contrave for weight loss. They will be seen weekly for the first 5 weeks and monthly for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly.	FA+ Contrave and Counseling n=10 Participants These participants will receive usual care of diet and physical activity recommendations and Contrave prescription and counseling (motivational interviewing interventions weekly for the first 5 weeks and then monthly for 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly. Contrave and Counseling: This group of participants will receive a combination of all the above interventions including diet/physical activity prescription, motivational interviewing and Contrave.	FA- Intervention Control n=13 Participants All participants will receive diet/physical intervention. One arm will receive diet/physical activity intervention alone as a Intervention/usual care condition. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages.	FA- Counseling n=14 Participants These participants will receive usual care and counseling in the form of motivational interviewing weekly with goal setting for the first 5 weeks and monthly intervention for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating.	FA-Contrave n=11 Participants These participants will receive usual care and prescription of Contrave for weight loss. They will be seen weekly for the first 5 weeks and monthly for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly.	FA- Contrave and Counseling n=10 Participants These participants will receive usual care of diet and physical activity recommendations and Contrave prescription and counseling (motivational interviewing interventions weekly for the first 5 weeks and then monthly for 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly. Contrave and Counseling: This group of participants will receive a combination of all the above interventions including diet/physical activity prescription, motivational interviewing and Contrave.	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	13 Participants n=21 Participants	14 Participants n=10 Participants	11 Participants n=115 Participants	10 Participants n=24 Participants	86 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	12 Participants n=21 Participants	13 Participants n=10 Participants	9 Participants n=115 Participants	9 Participants n=24 Participants	78 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=24 Participants	8 Participants n=42 Participants
Race/Ethnicity, Customized Ethnicity · White	7 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	6 Participants n=10 Participants	10 Participants n=115 Participants	7 Participants n=24 Participants	65 Participants n=42 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=24 Participants	19 Participants n=42 Participants
Race/Ethnicity, Customized Ethnicity · Native American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Region of Enrollment United States	8 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	10 participants n=4 Participants	13 participants n=21 Participants	14 participants n=10 Participants	11 participants n=115 Participants	10 participants n=24 Participants	86 participants n=42 Participants
Weight in lbs	231.9 Weight in Kilograms n=5 Participants	272.9 Weight in Kilograms n=7 Participants	221.7 Weight in Kilograms n=5 Participants	274.9 Weight in Kilograms n=4 Participants	250.5 Weight in Kilograms n=21 Participants	213.1 Weight in Kilograms n=10 Participants	242.9 Weight in Kilograms n=115 Participants	201.9 Weight in Kilograms n=24 Participants	238.7 Weight in Kilograms n=42 Participants
Body Mass Index (BMI) in Kilograms/m2	39 Kilograms/m2 n=5 Participants	42.1 Kilograms/m2 n=7 Participants	39.9 Kilograms/m2 n=5 Participants	40.7 Kilograms/m2 n=4 Participants	35.5 Kilograms/m2 n=21 Participants	35.2 Kilograms/m2 n=10 Participants	38.7 Kilograms/m2 n=115 Participants	35 Kilograms/m2 n=24 Participants	38.3 Kilograms/m2 n=42 Participants

PRIMARY outcome

Timeframe: difference between baseline and 6 months

Population: difference between first and last weight measure among each group

Weight in lbs

Outcome measures

Outcome measures
Measure	FA+ Intervention Control n=6 Participants All participants will receive diet/physical intervention. One arm will receive diet/physical activity intervention alone as a Intervention/usual care condition. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages.	FA+ Counselling n=8 Participants These participants will receive usual care and counseling in the form of motivational interviewing weekly with goal setting for the first 5 weeks and monthly intervention for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating.	FA+ Contrave n=8 Participants These participants will receive usual care and prescription of Contrave for weight loss. They will be seen weekly for the first 5 weeks and monthly for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly.	FA+ Contrave and Counseling n=9 Participants These participants will receive usual care of diet and physical activity recommendations and Contrave prescription and counseling (motivational interviewing interventions weekly for the first 5 weeks and then monthly for 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly. Contrave and Counseling: This group of participants will receive a combination of all the above interventions including diet/physical activity prescription, motivational interviewing and Contrave.	FA- Intervention Control n=9 Participants All participants will receive diet/physical intervention. One arm will receive diet/physical activity intervention alone as a Intervention/usual care condition. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages.	FA- Counseling n=10 Participants These participants will receive usual care and counseling in the form of motivational interviewing weekly with goal setting for the first 5 weeks and monthly intervention for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating.	FA-Contrave n=10 Participants These participants will receive usual care and prescription of Contrave for weight loss. They will be seen weekly for the first 5 weeks and monthly for the final 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly.	FA- Contrave and Counseling n=9 Participants These participants will receive usual care of diet and physical activity recommendations and Contrave prescription and counseling (motivational interviewing interventions weekly for the first 5 weeks and then monthly for 5 months. Intervention Control: diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages. Counselling: Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating. Contrave: In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly. Contrave and Counseling: This group of participants will receive a combination of all the above interventions including diet/physical activity prescription, motivational interviewing and Contrave.
Weight	-2.08 lbs Interval -8.7 to 4.7	-3.42 lbs Interval -10.6 to 3.2	-4.36 lbs Interval -7.5 to 3.6	-2.4 lbs Interval -10.4 to 4.4	-0.2 lbs Interval -7.1 to 5.9	-2.5 lbs Interval -9.1 to 4.3	-3.3 lbs Interval -9.6 to 1.8	-2.74 lbs Interval -10.2 to 6.9

PRIMARY outcome

Timeframe: difference between baseline and 6 months

Population: difference between first and last BMI measure among each group

Body Mass Index (BMI): Underweight Below 18.5, Normal 18.5-24.9, Overweight 25.0-29.9, Obesity 30.0 and Above