Clinical trial NCT01957800: Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
Official title: Enhancing the Sustainability of Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Keywords: weight loss
healthy diet
website
action planning
phone
social
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2013-10-08
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Body Weight
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: Demographics
timeFrame: 3 months
measure: Hospital and Anxiety Scale
timeFrame: 3 months
measure: International Physical Activity Questionnaire
timeFrame: 3 months
measure: Medications
timeFrame: 3 months
measure: Motivation scale
timeFrame: 3 months
measure: Three Factor Eating Questionnaire
timeFrame: 3 months
measure: Weight Loss Habits
timeFrame: 3 months
measure: Adherence
timeFrame: 3 months
measure: Satisfaction
timeFrame: 3 months
measure: Sedentary Behavior Questionnaire
timeFrame: 3 months
measure: Well Being
timeFrame: 3 months
measure: Weight Efficacy Questionnaire
timeFrame: 3 months
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Christopher Sciamanna, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: