University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT05612971
The purpose of this study is to assess whether providing a parent-only group program before providing a parent and child group program works better than the parent and child group program alone.
This study is active but is not currently recruiting participants.
6 year and older
All sexes
Interventional
Not applicable
Kansas City, Kansas, 66160, United States
The goal of this project is to determine if an adult intervention followed by a family-based program (iAmHealthy Parents First) will result in a larger percentage of weight loss in parents and children compared to solely a family-based program (iAmHealthy). Furthermore, the investigators aim to discover if administering iAmHealthy Parents First will improve dietary intake, physical activity, and weight-related quality of life among parents and children when compared to iAmHealthy. Parent/child dyads will be recruited from rural elementary schools, medical clinics, and organizations across Kansas and neighboring states.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
iAmHealthy Parents first is a 3-month adult obesity treatment program targeting the unique needs of adults with school-age children. Following the iAmHealthy Parents First program, these dyads will take part in a 6-month family-based healthy lifestyles program.
The iAmHealthy group will receive newsletters for three months. Following this period, these dyads will take part in a 6-month family-based healthy lifestyles program.
Time frame: Baseline, 3 months, 9 months
Parents and children will measure body weight on a study-provided digital scale following instructions provided by study team.
Time frame: Baseline, 3 months, 9 months
Group and individual session attendance (percent of sessions) will be tracked on REDCap, a secure, web-based application designed exclusively to support data capture for research studies.
Time frame: Baseline, 3 months, 9 months
Reciprocal influence (parent response as mediator for child; child response as mediator for parent) will be operationalized as adult or child weight loss.
Time frame: Baseline, 3 months, 9 months
Family functioning will be measured using the Family Assessment Device (FAD). This is the gold-standard measure of structural, organizational, and transactional characteristics of families including general family functioning (core scale of interest) and 6 additional subscales: affective involvement, affective responsiveness, behavioral control, communication, problem solving, and roles. This questionnaire will be completed by adults. The FAD is scored by adding responses of each scale (1 - 4) and dividing by the number of items in each scale (between 6 - 12). The higher the overall score, the worse the level of family function.
Time frame: Baseline, 3 months, 9 months
Genetic casual attributions will be measured using a a 2-item Likert scale that assesses perceived genetic role for weight status and potential for weight loss. This will be completed by adults. Those who endorse completely or mostly for the role of genes in weight loss will be characterized as having "high genetic attribution" for weight status.
Time frame: 9 months
Reach (participation rates and representativeness) will be assessed at primary care versus school settings. Participation rates will be calculated in multiple ways to include: 1) the percentage of individuals on lists who respond and 2) the percentage of eligible respondents who enroll. Enrolled participants will be classified as recruited from the school or clinic according to participant self-report of how they heard about the study, or if recruited from both channels, which one had the most influence on their participation. Representativeness will be assessed by comparing demographics (age/grade, sex, race/ethnicity, BMI where available) between enrolled participants and non-participants including 1) potential participants on recruitment lists and 2) those who are screened but do not enroll. In addition, the investigators will assess the impact of nurse engagement/leadership on participant reach and attendance.
Time frame: 1 month and 10 months
The Community Engagement Survey will assess nurse engagement and leadership, which is divided into seven separately summed subscales. Interview data collection and analysis will be led by Co-I who has the necessary training/experience to conduct semi-structured interviews, with assistance from members of the research team. Dedoose will be used to assist the researchers in efficient and organized data storage, coding, retrieval, comparing, and linking.
Time frame: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
This measure will be completed on a subset of participants. The Garmin activity device is a consumer wearable that will automatically detect and track activity such as walking, running, and cycling. This device will measures steps. Self-reported physical activity will be collected from the exercise vital sign.
Time frame: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
This measure will be completed on a subset of participants. Child diet will be parent reported using the Children's Eating Habits Questionnaire-Food Frequency Questionnaire section (CEHQ-FFQ). We are interested in the frequency of red foods ("junk" foods) and fruits/vegetables.
Time frame: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
This measure will be completed on a subset of participants. Child pain will be measured using the Pediatric Pain-Short form questionnaire from the Patient Reported Outcomes Measurement information system (PROMIS). Scores are summed and converted to T-scores using a conversion table. A T-score of 50 with a standard deviation of 10 is considered the mean. A minimally important difference in T-score is 3 points.
Time frame: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
This measure will be completed on a subset of participants. Home environment will be assessed through the Confusion, Hubbub, and Order Scale (CHAOS). Applicability of statements to respondent's own home environment is rated on a 4-point Likert-type scale: 1 (not at all), 2 (a little bit), 3 (somewhat), or 4 (very much). The range of scores is 15-60 with higher scores indicating a more negative home environment. Previous studies have grouped CHAOS scores into categories (low: <25; moderate/low: 25-30; moderate/high: 31-35; high: >35).
Time frame: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
This measure will be completed on a subset of participants. Caregiver stress will be assessed using the Perceived Stress Scale. Data will be analyzed/interpreted as a continuous variable and a categorical value. Responses to the scale are reported as a continuous variable (scores ranging from 0-47) and can be interpreted into one of three levels: low stress (scores 0-13), moderate stress (scores 14-26), or high stress (scores 27- 40). Higher scores correspond to higher levels of stress.
University of Kansas Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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