Ten2Twenty-Ghana: Study Design and Methods for an Innovative Randomized Controlled Trial with Multiple-Micronutrient–Fortified Biscuits among Adolescent Girls in Northeastern Ghana

Abstract

Investing in adolescent girls’ nutrition is vital for health and breaking intergenerational cycle of malnutrition and deprivation, but limited knowledge on the type, timing and efficacy of interventions delays progress. We describe the design of a 26-weeks randomised placebo-controlled trial with multiple-micronutrient fortified biscuits (MMB) among adolescent girls in north-eastern Ghana. Apparently healthy pre-menarche (n = 312) and post-menarche (n = 309) girls (10–17 yrs.) were randomised into receiving 5-day per week (i) MMB (fortified with 11 vitamins and 7 minerals) or (ii) unfortified biscuits. Data included plasma micronutrient status; anthropometry; body composition; cognitive function; psychosocial health; fertility; dietary intake, and socio-demographic and socio-economic covariates, complemented with in-depth interviews (n = 30) and 4 focus group discussions. We hypothesize that plasma ferritin and retinol-binding protein increase with a resultant increase in haemoglobin, cognition, vertical height and psychosocial health. Our study allows determining the efficacy and optimal timing of a multiple-micronutrient food intervention programme for adolescent girls.

Moderate-to-severe household food insecurity is associated with depression among adolescent girls in northern Ghana: a cross-sectional analysis

“…Throughout the fieldwork, supervisors checked and validated every questionnaire for consistency and completeness. The sample size selection and data collection are described in detail elsewhere 23. The RCT was also prospectively registered with the Netherlands Clinical Trials Register (NL7487).…”

Ten2Twenty-Ghana: a randomised controlled trial on the efficacy of multiple micronutrient-fortified biscuits on the micronutrient status of adolescent girls

“…Ten2Twenty-Ghana was a 26-week follow-up double-blind, RCT. The study design details, including the inclusion and exclusion criteria, have previously been described in detail elsewhere ( 23 ) . A non-targeted approach, including both anaemic and non-anaemic girls, was used to randomise girls within strata defined by menarche status (pre-and post-menarche) into two parallel treatment arms receiving nutrition/health education (5 different occasions) with either a 5-d weekly MMB or UB for 26 weeks.…”

“…The pre-trial run-in biscuits were procured from the open market and were similar in nutrient content to the UB and comparable in size (50 g) to both the MMB and UB. The research team and subjects were blinded in our investigation by repackaging the biscuits into clear zip-lock bags with yellow and red tags ( 23 ) .…”

Maternal nutritional status, decision-making autonomy and the nutritional status of adolescent girls: a cross-sectional analysis in the Mion District of Ghana

“…The sampling included four clusters, where four schools in the urban area were all selected, and fifteen larger rural schools were selected. A 16-item screening questionnaire ensured that all participating adolescent girls were pre- or post-menarche, healthy with no apparent signs of poor health, not pregnant and not lactating at the time of the survey (29) . Adolescent girls with missing data on haemoglobin (Hb) status ( n 4) and mothers with missing data on decision-making ( n 53) were excluded from the final analysis.…”

“…We analysed baseline data from the Ten2Twenty-Ghana study; the study design, setting, and population have previously been described in detail elsewhere (29) . In brief, Ten2Twenty-Ghana was a randomised controlled trial evaluating the efficacy of multiple-micronutrient fortified biscuits compared with unfortified biscuits on micronutrient status, height and cognition of adolescent girls aged 10-17 years in the Mion District, in north-eastern Ghana.…”