Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
NCT Number: NCT01957800
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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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Hershey, Pennsylvania, 17033, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Website will have action planning with social interactions and support features for sharing, reusing, and recommending strategies for improving habits.
Participants will record their weight and complete surveys online.
Time frame: 3 months
Body weight will be measured by a research assistant using a portable, digital scale.
Time frame: 3 months
We will measure age, gender, race and ethnicity, smoking status, education and other demographics, based on standard self-report.
Time frame: 3 months
This self-assessment scale has been found to be a reliable instruction for detecting states of depression and anxiety.
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.
Time frame: 3 months
We will measure dose and quantity of all prescribed medications based on standard self-report.
Time frame: 3 months
This questionnaire asks participants how motivated they are to control their weight using non-comparative scaling.
Time frame: 3 months
The questionnaire measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.
Time frame: 3 months
This questionnaire asks participants to rate their frequency of use of weight loss habits using non-comparative scaling.
Time frame: 3 months
We will examine daily journal completion data overall (mean and median) and as percentage.
Time frame: 3 months
This questionnaire asks participants to provide feedback about the study.
Time frame: 3 months
Time frame: 3 months
Time frame: 3 months
Milton S. Hershey Medical Center
Other
Enhancing the Sustainability of Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
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