Weight Loss Clinical Trial
Official title:
Effectiveness of A Coordinated Parent/Child Dyad Weight Loss Intervention:
NCT number | NCT04036331 |
Other study ID # | IRB00059569 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 30, 2021 |
Est. completion date | June 2024 |
The purpose of this research is to determine the effectiveness of 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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
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: - BMI < 30 - Contraindication for physical activity or caloric restriction - Cannot read or write English |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Institutes of Health (NIH) |
United States,
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* Note: There are 37 references in all — Click here to view all references
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. | 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. | 6 months |
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