Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions

This study is not yet open for participant recruitment.
Verified September 2013 by Milton S. Hershey Medical Center
Sponsor:
Collaborator:
Penn State Clinical and Translational Sciences Institute
Information provided by (Responsible Party):
Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01957800
First received: September 30, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

A randomized controlled trial comparing the effects of the social-enabled internet weight loss and diet change intervention with the delayed treatment group for 3 months. We will study the effect of adding social interactions and supports to an Internet weight loss and diet change intervention. The website intervention will have action planning with social interactions and support features for sharing, reusing, recommending, and discussing strategies for improving habits. We hypothesize that the intervention group with access to the website will lose more weight than the delayed treatment group after three months.


Condition Intervention
Overweight
Obese
Behavioral: Website
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhancing the Sustainability of Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Body Weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Body weight will be measured by a research assistant using a portable, digital scale.


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Blood pressure will be measured by a research assistant using a digital blood pressure monitor.


Other Outcome Measures:
  • Demographics [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    We will measure age, gender, race and ethnicity, smoking status, education and other demographics, based on standard self-report.

  • Hospital and Anxiety Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This self-assessment scale has been found to be a reliable instruction for detecting states of depression and anxiety.

  • International Physical Activity Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The survey comprises a set of 4 questionnaires. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.

  • Medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    We will measure dose and quantity of all prescribed medications based on standard self-report.

  • Motivation scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This questionnaire asks participants how motivated they are to control their weight using non-comparative scaling.

  • Satter Eating Competency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This is a reliable and validated 16-question assessment tool, assessing the four components of eating competence.

  • Three Factor Eating Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The questionnaire measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.

  • United States Department of Agriculture Food Security [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This questionnaires asks participants about food security and government assistance programs.

  • Weight Loss Habits [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This questionnaire asks participants to rate their frequency of use of weight loss habits using non-comparative scaling.

  • Adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    We will examine daily journal completion data overall (mean and median) and as percentage.

  • Satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This questionnaire asks participants to provide feedback about the study.


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Website
Group will be asked to complete a daily plan online for specific situations that tempt people to overeat. The website can be accessed online using a computer or smart phone and will allow participants to view others' plans and contact other participants in this group. Participants will also be asked to enter their weight online every week.
Behavioral: Website
Website will have action planning with social interactions and support features for sharing, reusing, recommending, and discussing strategies for improving habits
Behavioral: Usual Care
Participants will have their weight and blood pressure measured and complete surveys online.
Active Comparator: Usual Care
Group will be given access to the online intervention after the 3-month study ends.
Behavioral: Usual Care
Participants will have their weight and blood pressure measured and complete surveys online.

Detailed Description:

Over the past two decades a very simple, low-cost and consistently effective intervention has been developed that we believe has potential to be disseminated online in primary care. The intervention, "action planning" (AP), is also known as "if-then planning" or "implementation intentions". Action Planning is one element of the process of self-regulation (Wing et al 2006; Luszczynska et al 2007), in which individuals identify (1) situations that challenge their ability to perform a behavior and (2) make a specific plan for what they will do when the situation is next encountered. Luszczynska and colleagues observed that adding a single session of action planning onto a portion-controlled meal intervention increased the weight lost from 2.1 kg to 4.2 kg (Luszczynska et al 2007). A meta-analysis of 94 studies using AP, nearly all of which included a single-dose, observed a mean effect size of Cohen's d=.65, consistent with a medium to large effect. Studies of repeated doses appear to have even greater effects (Chapman and Armitage 2010). Dr. Sciamanna recently completed a pilot feasibility study in which 53 subjects used an AP intervention for weight loss for 2 months. All subjects attended a 1-hour introductory session about the use of portion-controlled meals and pedometers. Subjects were then emailed one AP writing prompt each day, representing one of the 21 of the most common barriers to weight control (Bond et al 2001). Despite receiving no personalized feedback, over 2 months the subjects wrote action plans, on an average of 4.2 days per week. After 2 months, the average weight loss was 7.7 pounds. These adherence levels, though short-term, are greater than typical web-based weight control interventions included in a recent Cochrane review (Wieland 2012). This pilot study suggests that this low-cost intervention approach may have unusual levels of fidelity. Even though the average activities of user engagement with AP is quite high in the first two months, there is a slight decline toward the third month. In focus group discussions after a pilot conducted by Dr. Sciamanna in the Philadelphia area, participants of the pilot indicated consistent difficulties in coming up with ideas for habits that might be useful. These observations motivates this proposed study.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 21 years old
  • English speaking
  • BMI from 27-50 kg/m2
  • Access to the Internet at home or work for most days of the week
  • Ability to receive texts on mobile phone

Exclusion Criteria:

  • Pregnant or planning to become pregnant in the next 3 months
  • Planning on moving in the next 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01957800

Contacts
Contact: Lindsay Cover 7175317754 lcover@hmc.psu.edu
Contact: Andrea Johnson 7175317754 ajohnson6@psu.edu

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Active, not recruiting
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Penn State Clinical and Translational Sciences Institute
Investigators
Principal Investigator: Christopher Sciamanna, MD, MPH Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Christopher Sciamanna, MD, MPH, Professor of Medicine and Public Health Sciences; Division Chief of General Internal Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01957800     History of Changes
Other Study ID Numbers: 43474EP
Study First Received: September 30, 2013
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
weight loss
healthy diet
website
action planning
phone
social

Additional relevant MeSH terms:
Weight Loss
Overweight
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014