CClinicalTrials.gg
CompletedNCT01724632Updated May 30, 2017

LIVE SMART: Smartphone Intervention for Weight Control

An interventional study of Lifestyle Counseling in Overweight and Obesity, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by The Miriam Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
276
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Overweight
  • Obesity

Browse trials for

Keywords

  • Overweight
  • Obesity
  • Weight Loss
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 276 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
276 participants (actual)

Study arms

  • Active comparator
    Group 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 will be weighed individually at the start of each group meeting.

    Behavioral: Lifestyle Counseling

  • Active comparator
    Individual Treatment

    Participants who are assigned to individual treatment will attend one-on-one sessions with a weight loss counselor every month for 18 months.

    Behavioral: Lifestyle Counseling

  • Experimental
    Smartphone Treatment

    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.

    Behavioral: Lifestyle Counseling

Interventions

  • BehavioralLifestyle Counseling

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

06

What researchers measure

Primary outcomes

  1. Weight Loss

    Time frame: Change from baseline to 18-months.

Secondary outcomes

  1. Weight-related Behaviors

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

    Time frame: Change from baseline to 18-months.

Other outcomes

  1. Engagement with Smartphone Treatment system

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

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

07

Study locations

1 site
  • Weight Control and Diabetes Resarch Center
    Providence, Rhode Island 02903, United States
08

References and documents

Publications

  • Goldstein SP, Goldstein CM, Bond DS, Raynor HA, Wing RR, Thomas JG. Associations between self-monitoring and weight change in behavioral weight loss interventions. Health Psychol. 2019 Dec;38(12):1128-1136. doi: 10.1037/hea0000800. Epub 2019 Sep 26. PubMed 31556659 ↗
  • Thomas JG, Bond DS, Raynor HA, Papandonatos GD, Wing RR. Comparison of Smartphone-Based Behavioral Obesity Treatment With Gold Standard Group Treatment and Control: A Randomized Trial. Obesity (Silver Spring). 2019 Apr;27(4):572-580. doi: 10.1002/oby.22410. Epub 2019 Feb 19. PubMed 30779333 ↗
  • Bond DS, Thomas JG, O'Leary KC, Lipton RB, Peterlin BL, Roth J, Rathier L, Wing RR. Objectively measured physical activity in obese women with and without migraine. Cephalalgia. 2015 Sep;35(10):886-93. doi: 10.1177/0333102414562970. Epub 2014 Dec 4. PubMed 25475207 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01724632
Lead sponsor
The Miriam Hospital
Responsible party
John Graham Thomas (Assistant Professor (Research), The Miriam Hospital) — Principal investigator
First posted
Nov 12, 2012
Start date
Nov 2012
Primary completion
Aug 2016
Completion
Aug 2016
Last update
May 30, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion