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Completed

NCT Number: NCT04241939

Telephone Counseling and Numberless Scales to Overcome Barriers to Adolescent Weight Loss

This study tests the feasibility and acceptability of a numberless behavioral digital scale (BDS) intervention combined with motivational interviewing (MI) to affect lifestyle changes to promote weight loss in adolescents who are obese. Half of the participants will receive this intervention, while the other half will use a digital scale along with the standard adolescent weight loss program.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UTMB, League City, Texas, United States

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About this study

The proposed pilot project seeks to enhance motivation for lifestyle change in adolescents who are obese. It will test a novel intervention that combines modified MI-based counseling and BDS. We will test the feasibility of the intervention over a 12-week period, with 24-week follow-up compared to use of standard digital scale. All participants will undergo the standard adolescent weight loss program, which includes monthly clinic visits with dietary and physical activity counseling. The MI intervention will include modified MI, brief weekly telephone reinforcement, and use of a BDS. The BDS with its mobile app offers daily feedback through colors, daily missions to promote healthy habits, and weekly healthy tips from nutritionists. In addition to the primary outcome of feasibility (daily weighing) investigators will also explore the intervention's effect on motivation, psychological outcomes and various aspects of feasibility and acceptability.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 12 and 18 years
  • BMI greater than or equal to 95th percentile for age and sex group or BMI greater than or equal to 35 kg/m^2
  • Participant (not parent) is able to read and understand English (app is in English)
  • Smartphone device with Wi-Fi and app capability
  • Willingness to be randomized to any condition

Exclusion criteria

Age 19 years or older

  • Developmental delay
  • Inability to provide informed consent
  • Any medical condition that, in the opinion of the PI, would place the participant at increased risk
  • Use of an investigational agent in the 30 days prior to signing informed consent
  • History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would , in the opinion of the PI, make it difficult for the participant to comply with study procedures or follow instructions
  • Females who are pregnant or lactating, by verbal report
  • Pre-existing conditions (i.e paralysis, heart failure, severe autism or mental retardation, psychosis, etc.)
  • Prisoners
  • Lack of transportation

Treatment and study plan

Numberless BDS

Behavioral

Participants perform daily weighing using a numberless BDS with feedback from app (color codes, challenges), in conjunction with modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.

Digital Scale

Behavioral

Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program

Modified Motivational Interviewing

Behavioral

Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.

Primary outcomes

  1. Feasibility of Modified MI and BDS

    Time frame: 24 weeks

    Attendance at in-clinic visits, completion of weekly phone calls, and daily weighing based on BDS app data collected at 24 week assessment.

  2. Acceptability of Modified MI and BDS

    Time frame: 24 weeks

    Number of participants in each group who are lost to follow-up

Secondary outcomes

  1. Anthropometrics

    Time frame: 24 weeks

    Body Mass Index (BMI)

  2. Bio-impedence measures

    Time frame: 24 weeks

    Measures body fat (%)

  3. Anxiety

    Time frame: Change from 0 to 24 weeks

    Self-reported anxiety on a scale from 0 (not at all) to 3 (severely) using the Beck Anxiety Inventory

  4. Depression

    Time frame: Change from 0 to 24 weeks

    Self-reported depression screening on a scale from 0 (not at all) to 3 (nearly every day) using the PHQ-9: Modified for Teens

  5. Bio-impedence measures

    Time frame: 24 weeks

    Measures muscle mass (%)

  6. Bio-impedence measures

    Time frame: 24 weeks

    Measures visceral fat (%)

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Brief Telephone Counseling and Numberless Scales to Overcome Weight Loss Barriers in Underserved Adolescents

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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