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Completed

NCT Number: NCT02192905

Feasibility Trial of a Problem-Solving Weight Loss Mobile Application

The purpose of this research was to develop and test the feasibility of Habit, a weight loss mobile application that was designed to coach patients through their weight loss challenges. In a pilot trial in 43 obese participants, investigators tested the feasibility of the Smart Coach mobile application when paired with a shortened online-delivered (8-week) behavioral weight loss intervention. Feasibility outcomes included frequency and duration of usage of the mobile app and each feature, recruitment, and retention. Post-intervention focus groups discussed the feasibility and acceptability of the intervention. The investigators also performed exploratory analyses comparing conditions on problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

About this study

The investigators developed and tested the feasibility of Habit, a weight loss mobile app that includes common features such as self-monitoring, goal setting, and a social network, but even more importantly, an avatar-facilitated, idiographic problem solving feature that processes information intelligently to help patients identify solutions to their weight loss problems. In a pilot trial in 43 obese participants, investigators tested the feasibility of the Habit mobile application when paired with a shortened (8 week) behavioral weight loss intervention. Feasibility outcomes included frequency and duration of usage of the mobile app and each feature, recruitment, and retention. The investigators also performed analyses on problem solving skills and weight loss at 8 and 16 weeks, which will inform a subsequent randomized controlled efficacy trial. Data will support an efficacy trial of a Habit-assisted brief behavioral weight loss intervention relative to a brief behavioral weight loss intervention alone with 1 year follow-up. The investigators overarching goal is to develop mobile technology that reduces the intensity of lifestyle interventions as far as possible while preserving weight loss outcomes, to ultimately broaden reach.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion: Participants must 1) have a BMI between 30 and 45, 2) currently uses a smartphone with Android software, 3) have connectivity to the internet at home and work, 4) have PCP written clearance, and 5) age 18 or older.

Exclusion:

  • Ages <18
  • BMI <30 and >45
  • Does not currently use a smart phone with Android software version 4.4 or later
  • Does not use a smartphone supported by the app (will assess model and type of phone for each participant)
  • Does not have connectivity to the internet at home and work; or wifi access at home
  • Does not use smart phone regularly throughout the day
  • Has not used Android smartphone for at least a year
  • Has not used a weight loss mobile app in the last 6 months
  • Does not have a Facebook account, uses it infrequently, or does not actively engage on Facebook
  • Does not have a gmail account or is unwilling to create one
  • Does not have PCP written clearance
  • Bipolar disorder, substance abuse, psychosis, bulimia, or severe depression
  • Pregnant or lactating
  • Had bariatric surgery
  • Medication affecting weight
  • Adults unwilling to provide consent
  • Prisoners
  • Unable to read or understand English
  • Has type 1 or 2 diabetes
  • Have concerns about being audiotaped
  • Unable to walk unaided
  • Has any medical condition that precludes lifestyle changes

Treatment and study plan

Diabetes Prevention Program Lifestyle Intervention

Behavioral

Primary outcomes

  1. Feasibility (Total Uses)

    Time frame: 8-week follow-up

    Mean total uses of the problem solving function of the mobile application

  2. Feasibility (Total Habits Attempted)

    Time frame: 8-week follow-up

    Total amount of new habits attempted during the study

  3. Feasibility (Recruitment Rates)

    Time frame: Baseline

    Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43)

  4. Feasibility (Retention Rates)

    Time frame: 8-weeks

    Total attendance at groups and total withdrawn from the study

Secondary outcomes

  1. Problem Solving Inventory

    Time frame: 8-week follow-up

    The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0.

  2. % Weight Change

    Time frame: 8-week follow-up

    Measured in pounds with a digital scale

  3. % Weight Change

    Time frame: 16 week follow-up

    Measured in pounds with a digital scale

  4. Social Problem Solving Inventory

    Time frame: 16-week follow-up

    The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0.

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Worcester Polytechnic Institute

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2014
Registry last updated
Sep 28, 2018

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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