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OpenTrials
Completed

NCT Number: NCT01724632

LIVE SMART: Smartphone Intervention for Weight Control

The purpose of this study is to compare three methods of delivering behavioral weight loss treatment.Participants are randomly assigned to one of three 18-month weight loss treatments (group, individual, or smartphone treatment). Participants who are assigned to group treatment will attend group meetings weekly for the first 6 months, then every 2 weeks for 6 months, and then monthly for the final 6 months. Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months. Participants who are assigned to smartphone treatment will use a smartphone to learn and practice weight loss skills. They will also attend one-on-one sessions with a weight loss counselor every month for 18 months. Assessment visits are conducted at baseline, 6, 12, and 18 months.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weight Control and Diabetes Resarch Center

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index (kg/m2) of 25-45.
  • English language fluency
  • Ability to read at a 6th grade level
  • Availability to attend weekly treatment sessions in Providence, RI

Exclusion criteria

  • Any heart condition that limits ability to participate in physical activity
  • Chest Pain
  • Any cognitive of physical limitation that would preclude use of a smartphone
  • Serious mental illness
  • Historical or current eating disorder
  • Previous or planned bariatric surgery
  • Use of weight loss medication
  • Recent pregnancy or a plan to become pregnant in the next 6 months
  • Participation in a study at the Weight Control and Diabetes Research Center within the last two years
  • A weight loss of greater than 5% body weight in the last 6 months

Treatment and study plan

Lifestyle Counseling

Behavioral

Participants receive instructions for making healthy changes to their diet and physical activity habits.

Primary outcomes

  1. Weight Loss

    Time frame: Change from baseline to 18-months.

Secondary outcomes

  1. Weight-related Behaviors

    Time frame: Change from baseline to 18-months.

    Questionnaire measures of diet, physical activity, and other weight related behaviors such as self-monitoring.

Other outcomes

  1. Engagement with Smartphone Treatment system

    Time frame: Mueasured continuously for the 18-month treatment.

    Frequency and duration of use of intervention resources made available to the smartphone treatment arm.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 12, 2012
Registry last updated
May 30, 2017

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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