Clinical trial NCT04837586: Self-Weighing for Adolescents Seeking Obesity Treatment
Official title: Self-weighing for Weight Management in Adolescents Seeking Obesity Treatment: A Randomized Pilot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Obesity
Keywords: Obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 99
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 99 patients age 12 to \<18 years old with obesity (BMI \>/=95th percentile), will be randomized to one of three treatment interventions:

1. Usual Care
2. Usual Care plus advice to weigh daily on simple scale
3. Usual Care plus advice to weigh-daily on an EHR-connected scale

Survey data collected at baseline, 2, 4, 6, and 12-weeks, and qualitative interviews at 12 weeks, will assess acceptability, safety, self-efficacy, and BMI. Recruitment will also be assessed (% eligible patients who consent). In order to understand real-world feasibility of this intervention, the clinic staff will work with patients to connect the scales to Epic.

Detailed description: Obesity is a major public health issue because of its high prevalence and many health consequences. Obesity is driven by a dysregulation of the body's energy regulatory systems and is life-shortening. Obesity during the critical adolescent period increases risk of diabetes, cardiometabolic disease, all-cause mortality, and adulthood obesity. Rates of obesity-related cancers are increasing in younger populations. In addition to poorer health, individuals with obesity during adolescence are at risk for lower productivity, income, and likelihood of employment in adulthood, making obesity treatment and prevention important for reducing disparities. Despite consensus on the need for multi-component interventions for obesity, rates continue to climb for adolescents, youth of low-income backgrounds, and youth of racial/ethnic minority backgrounds. Clinicians cite lack of time and tools to help patients lose weight as barriers to weight counseling, and thus need practical, effective interventions they can feasibly disseminate from a busy clinical setting.

Self-weighing, grounded in behavior change theory, is effective for weight loss in adults. Self-monitoring is grounded in Social Cognitive Theory (SCT), which describes behavior change as happening with reciprocal interactions with one's environment, creating external and internal self-reinforcement. Self-monitoring is one such interaction that improves self-awareness through proximate self-measurement, and improves self-efficacy, self-control, and self-reinforcement. Self-weighing (SW) is a form of self-monitoring for weight loss that is grounded in SCT. Daily SW in adults has been associated with increased exercise and cognitive restraint, and reduced snacking, television watching, and consumption of sweets.

The investigator found no data on patient and parent perspectives on connecting scales to the EHR for daily weights in adolescents with obesity seeking obesity treatment.

99 patients age 12 to \<18 years old with obesity (BMI \>/=95th percentile), to be randomized to one of three treatment interventions:

1. Usual Care
2. Usual Care plus advice to weigh daily on simple scale
3. Usual Care plus advice to weigh-daily on an EHR-connected scale

Survey data collected at baseline, 2, 4, 6, and 12-weeks, and qualitative interviews at 12 weeks, will assess acceptability, safety, self-efficacy, and BMI. Recruitment will also be assessed (% eligible patients who consent). In order to understand real-world feasibility of this intervention, the clinic staff will work with patients to connect the scales to Epic.

Eligibility criteria: Inclusion Criteria for Adolescent:

* Ages 12 to \< 18 years
* Body mass index (BMI) \>/= 95th percentile

Exclusion Criteria for Adolescent:

* Score over 20 on the Eating Attitudes Test (EAT-26)
* Any unhealthy weight control behaviors
* Severe anxiety or depression
* Participation in another Pediatric Weight Management Clinic study
* Developmental delay
* Significant co-morbidity that might cause weight fluctuations in weight
* Current participation in a weight loss research study

Inclusion Criteria for Parent:

* Parent or legal guardian of the child participant
* Parent aged \> 18 years

Primary outcomes:
measure: Feasibility of connecting the Smart scales to the EHR and access home weights through the EHR
timeFrame: 12 weeks
measure: Feasibility of collecting daily weights.
timeFrame: 12 weeks
measure: Perceptions of daily weight tracking.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: M Health - Pediatric Weight Management Clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Carolyn Bramante, MD
role: PRINCIPAL_INVESTIGATOR
References: