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Completed

NCT Number: NCT02812264

Using an API to Commercialize an Evidence-Based Weight Loss Intervention

This study will test the effectiveness of a mobile application that uses an Application Program Interface (API) to distribute evidence-based weight loss interventions. Half of the participants will receive this API-based application, and the other half of the participants will use a non API-based application.

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Key information

Conditions

Weight Loss Behavior Body Weight Body Weight Changes Health Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coeus Health Offices

State College, Pennsylvania, 16801, United States

About this study

The purpose of this study is to test a weight loss app that uses an API to disseminate an evidence-based weight loss intervention. The investigators hypothesize that, over the course of 12 months, participants using the Leaner app will have lost more weight than those in the attention control group.

Participants (n=206) will be randomly assigned to use either the intervention app (intervention arm; n=103) or a weight loss app of their choosing (attention control arm; n=103) for 12 months. Assessments will take place at baseline, and 3, 6, and 12 months.

Statistical analysis: A linear mixed modeling approach will be used to test the hypothesis. Observed weight vs. time plots will be analyzed for all participants to discern general trends in weight change. The model will include an intervention effect, a time effect, an intervention by time interaction, and a random intercept.

In exploratory analysis, investigators will examine weight change across subgroups of interest; investigators will add the subgroup variable and its interaction with the intervention indicator to the primary model. All analyses will be evaluated at the 0.05 significance level.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • informed consent
  • between 21-65 years old
  • BMI between 25-40 kg/m2
  • ownership and use of an Android smartphone during past 6 months with no plans to change phone/service during study
  • consent for research team to monitor app utilization

Exclusion criteria

  • use of weight loss medication
  • prior or planned bariatric surgery
  • psychiatric hospitalization in past 12 months
  • pregnancy, nursing, or planned pregnancy during the study
  • history of cardiovascular disease (CVD) event
  • self-reported history of an eating disorder
  • use of medication for diabetes mellitus
  • mobility restrictions for which exercise is contraindicated
  • history of a condition (e.g., lithium, steroids, anti-psychotics) that would affect weight measurement, for which weight loss is contraindicated
  • current participation in another weight treatment study and/or recent weight loss >10%
  • investigator discretion for safety reasons

Treatment and study plan

API App

Behavioral

Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale

Non-API App

Behavioral

Mobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale.

fitness tracker

Behavioral

fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app

Other names: wearable

scale

Behavioral

Connected scale that will transfer weight information to app

Other names: weight

Primary outcomes

  1. Weight change

    Time frame: up to 12 months

    Change in body weight over course of study

Secondary outcomes

  1. Weight Change - 3 months

    Time frame: up to 3 months

    Initial weight change

  2. Weight Change - 6 months

    Time frame: up to 6 months

    mid-point weight change

  3. Automated Self-Administered 24-hour Dietary recall (ASA-24)

    Time frame: baseline, 3-, 6-, 12-months

    Dietary patterns/24-hour dietary recall

  4. Physical Activity

    Time frame: baseline, 3-, 6-, 12-months

    Paffenbarger survey to capture physical activity patterns. Assesses self-report leisure time physical activity and weekly kilocalorie expenditure.

  5. Blood Pressure

    Time frame: baseline, 3-, 6-, 12-months

    Using a blood pressure cuff, measured three times at 1-minute intervals after 5 minutes of quiet sitting. Average of final two measurements is used.

  6. Fasting Lipid Profile

    Time frame: baseline, 3-, 6-, 12-months

    finger stick blood samples will be collected, following an overnight fast, to analyze fasting lipid profile. Samples will be analyzed using the Cholestech LDX

  7. Plasma Glucose

    Time frame: baseline, 3-, 6-, 12-months

    finger stick blood samples will be collected, following an overnight fast, to analyze plasma glucose. Samples will be analyzed using the Cholestech LDX

  8. High Sensitivity C-Reactive Protein

    Time frame: baseline, 3-, 6-, 12-months

    finger stick blood samples will be collected, following an overnight fast, to analyze high sensitivity c-reactive protein. Samples will be analyzed using the Cholestech LDX

  9. Patient Health Questionnaire (PHQ) 9

    Time frame: baseline, 3-, 6-, 12-months

    Nine-item self-report assessment of depression severity.

  10. Body Shape Questionnaire (BSQ)

    Time frame: baseline, 3-, 6-, 12-months

    8-item self-report questionnaire about concern with body shape.

  11. Mizes Anorectic Cognitions Questionnaire - Revised (MAC-R)

    Time frame: baseline, 3-, 6-, 12-months

    24-item self-report measure of disordered eating cognitions.

  12. Questionnaire of Eating and Weight Patterns

    Time frame: baseline, 3-, 6-, 12-months

    Eight-item self-report measure of binge eating behaviors.

  13. Medical Outcomes Survey: Social Support

    Time frame: baseline, 3-, 6-, 12-months

    19-item self-report assessment of social support.

  14. EuroQOL Health Related Quality of Life Scale

    Time frame: baseline, 3-, 6-, 12-months

    16-item self-report assessment of health related quality of life.

  15. The Health and Work Performance Questionnaire (HPQ)

    Time frame: baseline, 3-, 6-, 12-months

    Presenteeism/Absenteeism items from the self-report HPQ.

  16. App engagement

    Time frame: through study completion, an average of 1 year

    Using technology on smart phones, we will monitor participants' app usage throughout the course of the study.

Sponsors and collaborators

Lead sponsor

Coeus Health, LLC

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2016
Registry last updated
Jul 14, 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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