EAL

SSPSM: Nutrient Intake (2014)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose of this research was to evaluate the effects of different food provision strategies on weight loss.

Inclusion Criteria:

Between the ages of 25 and 44 years
Overweight
Non-smoker
Able to exercise
Not on a special diet
Free of serious disease.

Exclusion Criteria:

Not described.

Description of Study Protocol:

Recruitment: Not described
Design: Randomized controlled trial
Blinding used: Implied with measurements.

Intervention

In the first study, participants were randomized to one of five groups: Standard Behavior Therapy Group (SBT); SBT Plus Food Provisions; SBT Plus Incentives; SBT Plus Food Provision Plus Incentives Group; Control Group
In the second study, participants were randomized to one of four groups: An SBT Group; SBT Plus Menu Group, SBT Plus Buy Food Group; SBT Plus Free Food Group.

Statistical Analysis

Not described.

Data Collection Summary:

Timing of Measurements

Benefits of food provision were observed through 18 months
Participants were weighed at six, 12, 18 and 30 months to determine long-term impact of the intervention.

Dependent Variables

Weight loss measured at six, 12, 18 and 30 months.

Independent Variables

In the first study, participants were randomized to one of five groups: Standard Behavior Therapy Group (SBT); SBT Plus Food Provisions; SBT Plus Incentives Group; SBT Plus Food Provision Plus Incentives Group; Control Group.
- Standard Behavior Therapy Group: Consisted of weekly group sessions for 20 weeks followed by monthly group sessions and weekly weigh-ins for the remainder of the 18-month program. Exercise, primarily walking or biking was stressed with gradual increasing goals until burning 1,000kcal per week.
- SBT Plus Food Provision: This group received all of the same components as above, but they were also given pre-packaged meals for five breakfasts and five dinners each week throughout the 18-month program. The meals provided 1,000-1,500 calories.
- SBT Plus Incentives: Participants received the SBT program plus payments of $25 per week for reaching weight loss goals
- SBT Plus Food Provision Plus Incentives: Participants received all of the intervention strategies mentioned for the Food Provision Group as well as the Incentives Group
- Control Group: These participants received no intervention but attended assessment visits at 6, 12 and 18 months.
In the second study, participants were randomized to one of four groups: An SBT Group; SBT Plus Menu Group; SBT Plus Buy Food Group; SBT Plus Free Food Group
- SBT: The treatment program involved 26 weekly treatment meetings only (i.e., six months rather than 18 months of active treatment)
- SBT Plus Menu: This group received the SBT program and was given written meal plans indicating the type and amount of food that they should consume for five breakfasts and five dinners each week. Weekly grocery lists were provided to assist in purchasing these items.
- SBT Plus Buy Food: These individuals received the same SBT program and the same menus as Groups One and Two, but were given a box of food each week that contained all of the food described in the menu plan. Participants were paid $25 each week for this food.
- SBT Plus Free Food: These participants received the same meal plans and box of food, but was given the food for free.

Description of Actual Data Sample:

Initial N: 202 subjects in Study One (sex not described); 163 overweight women in Study Two
Attrition (final N): 177 subjects completed 30 months (88%) in Study One; 146 women (90%) in Study Two
Age: Mean age, 37.4 years (range, 25 to 44 years) in Study One; mean age, 41 years in Study Two
Ethnicity: Not reported
Other relevant demographics: Not reported
Anthropometrics: Mean BMI, 31.0kg/m² in Study One; mean BMI, 32.0kg/m² in Study Two
Location: Minneapolis, MN and Pittsburgh, PA.

Summary of Results:

Key Findings

Study One

In the first study, at six, 12, and 18 months, weight losses in the two groups receiving food provision were significantly greater than in the two groups without food provision
Average weight losses for the two groups given food provision were 10.1kg, 9.1kg and 6.4kg at six, 12, and 18 months, respectively, compared with 7.7kg, 4.5kg and 4.1kg at these same times in groups receiving the same treatment without food provision
Food provision increased initial weight losses by 31%. Benefits of food provision were observed through 18 months. There was no effect of financial incentives.
Men and women benefited similarly from the food provision intervention and the effect was observed at both of the research sites
At 30 months, participants in the control condition had gained 0.6kg from baseline. The four active treatments all had maintained some weight loss at 30 months: 1.4kg in SBT, 2.2kg in SBT Plus Food, 1.6kg in SBT Plus Incentives and 1.6kg in SBT Plus Food Plus Incentives. However, at 30 months, there were no differences in weight losses among the intervention conditions.
In Study One, the food provision condition reported lower dietary fat intake over the 18-month program relative to the other treatment conditions
In Study One, participants in the food provision conditions became significantly more accurate than the other groups at estimating the number of calories in a list of common food items, which may have resulted from the fact that they were provided with specific information about the portion sizes and the number of calories and fat grams in each food item that was provided to them
Adherence to self-monitoring was positively affected by food provision, as reducing the time and effort of planning meals simplified the task of following the prescribed diet; in Study One, completion of eating and exercise diaries in the SBT groups averaged 67% during Weeks One to 20, 33% during Weeks 21 to 52 and 23% during Weeks 53 to 78, while completion of diaries in the food provision condition averaged 87%, 61% and 37% of the weeks during these three periods, respectively.

Study Two

In the second study, Groups Two, Three and Four all had better weight losses than SBT and did not differ from each other at the end of the six-month treatment and at the 18-month follow-up
The finding that food provision improves weight loss compared with a standard behavioral program was
clearly replicated. However, this study showed, in addition, that the most important aspect of food provision was not the food, but rather the structured meal plans.
Giving meal plans and grocery lists was sufficient to increase initial weight loss by 50% at six months (from eight kg to 12kg) and by 100% one year later (from 3.3kg to 6.9kg).

Author Conclusion:

Food provision and menus were associated with increased behavior compliance, increased nutrition knowledge, more regular meals and fewer snacks, reduced barriers to weight loss and improved quality of foods in participants’ homes
Food provision seems to be a useful strategy for promoting weight loss.

Funding Source:

Government:

NIH Grant # HL41330 and HL41332

Reviewer Comments:

Recruitment methods not reported
Sample not well described
Statistical analysis not described.

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?		No
	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?	No
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
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)	Yes
	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?		Yes
	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.)	Yes
	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?		No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	???
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	No
	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)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	???
	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