A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)

Weight Loss Clinical Trial

Official title:

A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811743
• Other study ID #: IRB00055004
• Status: Completed
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: June 16, 2020

Study information

• Verified date: May 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to develop a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.

Description:

Participation in this study will involve participation in six, one-hour sessions in addition to those required by your weight loss program. These sessions will work to facilitate an increase in self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs. Joint goal setting and tracking will be enabled by commercially available devices and apps. Each caregiver and child will receive an activity monitor, activity app, and a food app (digital food diary) that allows self-monitoring of consumption and "social accountability," which will allow caregivers and the Brenner FIT team to monitor and encourage. Furthermore, two home visits will be conducted to evaluation the home food and activity environments to inform tailored feedback to families.

Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old referred by a physician for overweight or obesity.11-14 By Design is an adult (>18yrs) weight loss clinic that includes tailored dietary and physical activity behavioral counseling. The preliminary data suggest that most adolescent youth who enroll in Brenner FIT have at least one adult caregiver who is eligible and would benefit from enrollment in By Design Essentials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 16, 2020
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

Inclusion Criteria:

• Eligible for enrollment in Brenner FIT and/or By Design Essentials

• Caregiver who lives in the house with a BMI > 30

• No contraindication for physical activity or caloric restriction

• Must be able to read and write English

Exclusion Criteria:

• Over the age of 65

• BMI < 30

• Contraindication for physical activity or caloric restriction

• Cannot read or write English

Related Conditions & MeSH terms

• Body Weight
• Pediatric Obesity
• Weight Loss

Intervention

Behavioral:
• Brenner FIT
Brenner FIT pediatric weight management program enrollment. an interdisciplinary, family-based pediatric weight management clinic based upon the Familial Approach to Treatment of Childhood Obesity. Patients are referred by a physician for obesity or overweight with a weight-related comorbidity. Treatment teams are comprised of a pediatrician, counselor, dietitian, and physical activity specialist, with others (e.g., social workers, physical therapists) as needed. The entire family is encouraged to attend all aspects of the treatment program, although only one attending caregiver is required.
• By Design
Weight loss program for adults/caregivers of those enrolled in Brenner FIT. Participants in the By Design condition (adult caregivers) will be prescribed the Essentials lifestyle intervention which includes tailored dietary and physical activity goals designed to achieve 1-2 lbs./week of weight loss, provided by a multidisciplinary team of medical providers, dietitians, behaviorists, and exercise specialists. A daily calorie restriction of 500 kcal/day is prescribed based on estimates of total energy expenditure (TEE) obtained from a measured resting metabolic rate (RMR) prior to enrollment.
• Coordination
This component adds four additional strategies: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. This innovative approach will seek to employ components of motivation and communication theories to increase self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs beyond gains observed in matched controls. Essentials (adults), with four additional components: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

Skelton JA, Beech BM. Attrition in paediatric weight management: a review of the literature and new directions. Obes Rev. 2011 May;12(5):e273-81. doi: 10.1111/j.1467-789X.2010.00803.x. Epub 2010 Sep 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI z-score	Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.	Baseline
Primary	BMI z-score	Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.	3 Months
Primary	BMI z-score	Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.	6 months
Secondary	Physical Activity Assessed by Accelerometry	Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.	Baseline
Secondary	Physical Activity Assessed by Accelerometry	Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. Moderate to vigorous activity will be measured in minutes.	6 months
Secondary	Physical Activity Assessed by PAQ-A	The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity.; The PAQ-A ranges from 1-7. Higher score denotes better outcome.	Baseline
Secondary	Physical Activity Assessed by PAQ-A	The Physical Activity Questionnaire for Adolescents (PAQ-A) will be given to assess physical activity.; The PAQ-A ranges from 1-7. Higher score denotes better outcome.	6 months
Secondary	Physical Activity Assessed by IPAQ	The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults.; The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.	Baseline
Secondary	Physical Activity Assessed by IPAQ	The International Physical Activity Questionnaire (IPAQ) will be given to assess physical activity in adults.; The IPAQ ranges from 10-960 minutes/day of physical activity. Higher score denotes better outcome.	6 months
Secondary	Caloric intake expressed in kcals	Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.	Baseline
Secondary	Caloric intake expressed in kcals	Diet will be assessed by the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.	6 months
Secondary	Concentration of fasting glucose for all participants, mg/dL	Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.	Baseline
Secondary	Concentration of fasting glucose for all participants, mg/dL	Fasting blood glucose will be ascertained for each participant. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is optimal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes.	6 months
Secondary	Concentration of fasting Insulin for all participants, mg/dL	Fasting insulin levels will be gathered from all participants.	Baseline
Secondary	Concentration of fasting Insulin for all participants, mg/dL	Fasting insulin levels will be gathered from all participants.	6 months
Secondary	Hemoglobin A1c concentration for all participants, measured in percentage	Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% Values greater denote diabetes.	Baseline
Secondary	Hemoglobin A1c concentration for all participants, measured in percentage	Normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4%. Values greater denote diabetes.	6 months
Secondary	Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)	AST a useful test for detecting or monitoring liver damage.	Baseline
Secondary	Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)	AST a useful test for detecting or monitoring liver damage.	6 months
Secondary	Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter	A low level of ALT in the blood is expected and is normal.	Baseline
Secondary	Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter	A low level of ALT in the blood is expected and is normal.	6 months
Secondary	Concentration of total cholesterol (mg/dL)	total cholesterol: less than 200 mg/dL	Baseline
Secondary	Concentration of total cholesterol (mg/dL)	total cholesterol: less than 200 mg/dL	6 months
Secondary	Economic costs of the three intervention arms over duration of program (USD)	Clinical and non-clinical costs of the interventions will be compiled over the duration of the program. All cost will be reported in the same unit.	Baseline through 6 months