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Completed

NCT Number: NCT01957800

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

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 21-65 years old
  • English speaking
  • BMI from 27-50 kg/m2
  • Access to the Internet at home or work for most days of the week
  • Have current service for a smart phone with a camera and texting capability
  • Able to use mobile phone to take a picture and send it to someone
  • Able to use mobile phone to look for information on the internet using a search engine (such as Google)
  • Able to use mobile phone to send and receive text messages
  • Able to use mobile phone to send and receive emails
  • Access to a scale at home

Exclusion criteria

  • Pregnant or planning to become pregnant in the next 3 months
  • Planning on moving out of the area in the next 6 months
  • Weigh more than 300 pounds
  • Participating in an internet or community weight loss program
  • Taking medication, prescription or over the counter for weight loss
  • Doctor has said you have a heart condition and should only do physical activity recommended by a doctor
  • Feel pain in chest when doing physical activity
  • In the past month feel pain in chest when not doing physical activity

Treatment and study plan

Website

Behavioral

Website will have action planning with social interactions and support features for sharing, reusing, and recommending strategies for improving habits.

Usual Care

Behavioral

Participants will record their weight and complete surveys online.

Primary outcomes

  1. Body Weight

    Time frame: 3 months

    Body weight will be measured by a research assistant using a portable, digital scale.

Other outcomes

  1. Demographics

    Time frame: 3 months

    We will measure age, gender, race and ethnicity, smoking status, education and other demographics, based on standard self-report.

  2. Hospital and Anxiety Scale

    Time frame: 3 months

    This self-assessment scale has been found to be a reliable instruction for detecting states of depression and anxiety.

  3. International Physical Activity Questionnaire

    Time frame: 3 months

    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.

  4. Medications

    Time frame: 3 months

    We will measure dose and quantity of all prescribed medications based on standard self-report.

  5. Motivation scale

    Time frame: 3 months

    This questionnaire asks participants how motivated they are to control their weight using non-comparative scaling.

  6. Three Factor Eating Questionnaire

    Time frame: 3 months

    The questionnaire measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.

  7. Weight Loss Habits

    Time frame: 3 months

    This questionnaire asks participants to rate their frequency of use of weight loss habits using non-comparative scaling.

  8. Adherence

    Time frame: 3 months

    We will examine daily journal completion data overall (mean and median) and as percentage.

  9. Satisfaction

    Time frame: 3 months

    This questionnaire asks participants to provide feedback about the study.

  10. Sedentary Behavior Questionnaire

    Time frame: 3 months

  11. Well Being

    Time frame: 3 months

  12. Weight Efficacy Questionnaire

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Penn State University

Registry information

Official study title

Enhancing the Sustainability of Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2013
Registry last updated
Sep 1, 2015

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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