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MNT: Special Needs (2015)

Citation:
Ptomey LT, Sullivan DK, Lee J, Goetz JR, Gibson C, Donnelly JE. The use of technology for delivering a weight loss program for adolescents with intellectual and developmental disabilities. J Acad Nutr Diet. 2015; 115(1): 112-118. PubMed ID: 25441960
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:
  • To determine the feasibility of using tablet computers as a weight loss tool
  • To compare the effectiveness of two weight-loss diets and enhanced Stop Light Diet (eSLD) and a conventional diet (CD) in overweight and obese adolescents with intellectual and developmental disabilities.
Inclusion Criteria:
  • Age 11 to 18 years
  • Intelligence quotient of 50 to 69 (mild) or 35 to 49 (moderate)
  • Overweight or obese (BMI higher than 85th percentile on Centers for Disease Control and Prevention growth charts)
  • Living at home with a parent
  • Access to a wireless internet connection.
Exclusion Criteria:
  • Insulin-dependent diabetes
  • Participated in a weight-reduction program during the past six months
  • Being treated for major depression or eating disorders
  • Consuming special diets
  • A diagnosis of Prader-Willi syndrome
  • Pregnant or became pregnant during the study. 
Description of Study Protocol:

Recruitment

Participants were recruited through local community programs and advertisements in the target area using flyers and e-mail. Initial eligibility screenings were completed via telephone or e-mail. Home visits were scheduled with interested parents and potential participants for explanation and to obtain parental consent and adolescent assent. All parents or guardians signed a consent form and adolescents gave oral assent to participate. 

Design

In this eight-week pilot investigation, participants were randomized to either the eSLD or CD and were given an iPad for the duration of the study to track dietary intake and physical activity. At baseline a 90-minute at-home diet orientation session was conducted by a registered dietitian nutritionist (RDN) with the participant and a parent. They then participated in weekly at-home sessions conducted over video chat (FaceTime) on the iPad. One parent was asked to be the study helper; they attended orientation and all weekly education sessions, helped track food intake and physical activity on the iPad if needed, and provide encouragement by helping with meal preparation and encouraging physical activity. All participants completed outcome assessments at baseline and at the end of week eight. The eSLD included the Stop Light Diet with the addition of more than five servings per day of fruits and vegetables and high-volume, low-energy, portion-controlled meals (PCMs) consisting of two entrees and two shakes per day. Non-caloric beverages were allowed at will. All PCMs were provided and were delivered to participants' homes. Participants were to consume two entrees and two shakes per day. If they were still hungry or couldn't have a PCM, they were to choose foods in the green or yellow foods category but to avoid foods in the red category. Participants in the CD were instructed to consume a higher-volume, lower-fat (20% to 30% of energy) diet as recommended by the USDA's MyPlate. A calorie deficit of 500kcal to 700kcal per day was prescribed, with no less than 1,200kcal per day. Examples of nutritionally balanced meals based on energy needs were provided to participants and they were encouraged to have five servings of fruits and vegetables per day. Participants were also educated on appropriate portion sizes. Also, all participants were to build up to 60 minutes of physical activity per day at least five days a week. During the first week of intervention, participants were to exercise 10 minutes per day and add another 10 minutes every week until 60 minutes per day was achieved. Participants were asked to wear a wireless activity monitor (FitBit Ultra) for the health educator to monitor progress and provide feedback. On the iPad, participants used the application LoseIt! to track all foods and beverages. The FitBit monitors synced all data collected to the iPad. Finally, participants and parents used FaceTime video chat with the RDN for 30 minutes once a week on the iPad during a weekday evening at a time and date set by the parent and participant during orientation. During the video chat, participants had a brief lifestyle modification session covering social support, self-monitoring, physical activity, environmental control and self-efficacy. Copies of all eight lessons were available on the iPad. The RDN also reviewed diet and physical activity data and answered questions, problem-solved and helped foster goal setting. 

Intervention

Participants were randomly assigned to either the eSLD or the CD and were provided with iPads to track food intake and physical activity, as well as to video chat weekly with an RDN.

  • On the eSLD, participants:
    • Used PCMs  consisting of two entrees and two shakes per day
    • Drank non-caloric beverages at will
    • Chose foods from the green light and yellow light food categories if they were still hungry or not able to consume a PCM
    • Avoided foods in the red light category. 
  • On the CD, participants:
    • Followed the USDA MyPlate approach for a higher volume, lower-fat (20% to 30%) and balanced diet
    • Were prescribed 500kcal to 700kcal per day energy deficit, but not consuming less than 1200kcal per day
    • Were encouraged to eat five servings of fruits and vegetables per day.

Statistical Analysis

Descriptive statistics were used to summarize sample demographics and all outcome measures. Bivariate tests compared groups at baseline and at the end of month two, as well as changes from baseline to month two. General mixed modeling was used to examine group, time and group-by-time interaction effects on accelerometry variables. General linear modeling was used to examine group effects on the change in other outcomes. Covariates like participants' ages, sex, races and levels of IDD were included in the models.

Data Collection Summary:

Timing of Measurements

  • Weight was measured at baseline, week four and week eight
  • Height was measured at baseline and week eight
  • All participants wore an ActiGraph Model CT3 for four consecutive days (two weekdays and two weekend days) at baseline and the end of week eight to assess physical activity levels
  • Three-day photo-assisted diet records were used at baseline and the end of week eight to assess dietary intake; participants (with parental help) wrote down all foods and beverages consumed over three days (two weekdays and one weekend day) and used the iPad to take pictures of all meals consumed at home on those days
  • Participants' use of the LoseIt! app and FitBit activity tracker were reviewed by the RDN to determine the number of days during the eight-week intervention participants were able to track at least one meal and wear the FitBit to get physical activity data
  • At the end of week eight, participants completed a questionnaire assessing comfort using the iPad, tracking food and activity and using video chat.

Dependent Variables

  • Weight loss (kg)
  • Change in waist circumference (cm)
  • Increase in physical activity (as measured by FitBit tracker)
  • Change in energy and macronutrient intake (as measured by three-day, photo-assisted food records)
  • Change in diet quality (as measured by Healthy Eating Index 2010)
  • Frequency and ease of iPad use for tracking food and activity (frequency calculated by reviewing number of days with data, ease assessed by questionnaire at week eight)
  • Attendance at weekly video chats with RDN.

Independent Variables

  • eSLD
  • CD
  • Use of iPad.
Description of Actual Data Sample:
  • Initial N: N=20 (45% female)
  • Attrition (final N): N=20
  • Age: 14.9 ± 2.2 years
  • Ethnicity: Of the 20 participants, one was Asian, four were black, 14 were white and one was mixed race. No participants were Hispanic/Latino.
  • Other relevant demographics: Twelve of the participants had mild IDD while eight had moderate IDD. Nine participants also had autism, eight had Down syndrome and three had another secondary diagnosis.

Anthropometrics

  • All participants had at 91.6±6.1 percentile BMI-for-age
  • Baseline weight in the eSLD group was 82.3±29.8kg and 65.1±25.3kg for the CD group (P=0.180)
  • Baseline BMI for the eSLD group was 30.7±7.3kg/m2 and 26.9±5.3kg/m2 in the CD group (P=0.192)
  • Waist circumference at baseline for the eSLD group was 89.8±17.0cm and 80.6±12.6cm in the CD group (P=0.185).

Location

University of Kansas, Lawrence, Kansas.

Summary of Results:

Key Findings

  • At eight weeks:
    • No significant difference between groups; however, both had improvements in weight (-3.9kg eSLD; -2.2kg CD)
    • Percent weight loss (-4.6% eSLD; -3.3% CD)
    • BMI (-1.6kg/m2 eSLD; -1.0kg/m2 CD)
    • BMI percentile (-3.1 eSLD; -4.5 CD)
    • Waist circumference (-2.8cm eSLD; -3.2cm CD)
    • HEI index (+5.8 points eSLD; +4.5 points CD). 
  • Participants in both diet groups were able to lose weight and there were no significant differences in weight loss between the eSLD and CD groups (-3.9±2.7kg vs. -2.2±1.4kg, P=0.094 between; P<0.001 within groups)
  • Covariates that significantly affected weight change were race (weight change in kg, P=0.015; BMI change, P=0.036) and level of IDD severity (weight change in kg, P=0.005; percent weight change P=0.015; and BMI change, P=0.007)
  • After controlling for covariates, no significant group difference was observed in weight change (weight change in kg, P=0.485; percent weight change, P=0.988; BMI change, P=0.892; and BMI percentile change, P=0.781)
  • There was a significant decrease in sedentary activity at the end of week eight in both groups combined (P=0.028) but no significant difference between groups (P=0.855). There was also no significant difference in moderate (P=0.176) or vigorous (P=0.136) activity time.
  • For the eSLD, there was an 844.9±641.0kcal deficit between baseline and the end of week eight (P=0.002), and a 674.9±769.4kcal (P=0.030) deficit in the CD group. Participants in the eSLD had a significantly greater reduction of energy intake compared with those in the CD group (P=0.048). 
  • Total HEI-2010 increased in both groups, but the difference was not significantly different between groups (P=0.379)
  • Both groups entered food intake into the iPad 83.4%±21.3% of total days and had physical activity data for 60.0%±34.3% of total days in the study
  • Participants and parents attended an average of 80% of weekly video chat meetings with the RDN
  • A total of 95% of adolescents reported they enjoyed using the iPad and that it was easy to use. A total of 85% reported it was easy to enter foods into the LoseIt! application. A total of 42% of parents reported participants entered all data on their own, while, 26% reported they helped participants. A total of 32% of parents reported having to enter all data themselves. 
Author Conclusion:
Adolescents with IDD can lose significant weight following both a CD and eSLD diet in combination with guidance from an RDN. Tablet computers like iPads are a feasible aid in promoting weight loss in this patient population. 
Funding Source:
Industry:
Health Management Resources, Boston, MA
Pharmaceutical/Dietary Supplement Company:
Reviewer Comments:
  • Acronyms:
    • eSLD: Enhanced Stop Light diet
    • CD: Conventional diet
    • IDD: Intellectual and developmental delays
    • HEI: Healthy Eating Index
    • PCM: Portion controlled meal, provided by Health Management Resources, Boston MA.
  • Limitations: 
    • Small sample size
    • Short duration
    • Non-stratification between level of IDD severity
    • Both groups yielded improvements in health outcomes over eight weeks; however, P-values were only reported between groups.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) No
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) Yes
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
5. Was blinding used to prevent introduction of bias? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) No
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? Yes
  6.6. Were extra or unplanned treatments described? Yes
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? No
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes